Why it's used

Safetelmi Tablet is used to treat high blood pressure. It is a prescription medicine. This medicine works by blocking the action of vasoconstrictor agent which are responsible for increasing the blood pressure, by selectively blocking the binding of angiotensin II to its binding site, angiotensin receptor. This medicine helps by reducing the increased blood pressure by exerting blocking actions on the angiotensin receptor. Safetelmi is also used to reduce the risk of heart attack, stroke, or fatalities associated with heart failure in patients who are 55 years in age or older, who are at high risk of developing major heart damage events unable to take ACE blockers and patients with high blood sugar level (type 2 diabetes mellitus) with target organ damage.
Safetelmi Tablet may also be taken in combination with other medicines to treat certain conditions as recommended by the doctor. Safetelmi Tablet is used together with Antiplatelet drugs, or lipid-lowering drugs to reduce the risk of heart attack, stroke, or fatalities associated with heart failure in patients who are 55 years in age or older, who are at high risk of developing major heart damage events unable to take ACE blockers. Safetelmi is also used with hydorchlorthiazide, or other antihypertensives to treat high blood pressure.
Angiotensin 2 Receptor Blocker
Safetelmi belongs to a class of medicines called Angiotensin 2 Receptor Blocker. Angiotensin II receptor blockers are used for the treatment of high blood pressure and heart failure. These medicines act by relaxing the blood vessels and makes it easier for your heart to pump blood.

How to use

Follow directions on the product label, information guide, and provided by your doctor before using Safetelmi. Eat this medicine as per your doctor's instructions.
Safetelmi is eaten with or without food. Safetelmi tablets should be taken once a day orally with liquid, with or without food.
The typical adult dose of Safetelmi is 40 to 80 mg once a day. The maximum dose for adults of Safetelmi is 80 mg per day. This medicine is commonly used for a period of 4 weeks for high blood pressure. Safetelmi is typically used at the same time every day. To help the patient remember to take Safetelmi. It should be taken at the same time every day. It takes 3 hours for this medicine to start its action.
Safetelmi is to be used for longer periods of time. You should continue to use this medicine as directed by the doctor even if you feel well.
Tell your doctor if you develop new symptoms. Talk to your doctor if swelling in feet, ankles, or hands, and unexplained weight gain. If you have any kidney disease, a lower starting dose of 20 mg is suggested for patients with kidney damage. If you have issues with the health of your liver, Safetelmi should not be used in patients with severe liver damage. In patients with mild to moderate damage to the liver, the dose should not be given more than 40 mg once in a day. Consult with your doctor before stopping the use of Safetelmi Tablet.
To see the impact of Safetelmi Tablet on the body, your doctor may recommend a lower initial dose. Please follow your doctor's instructions carefully. Taking a high dose of this medicine is known to increase the chances of side-effects. A lower dose of Safetelmi Tablet may be recommended to reduce the risk of side-effects. Older patients may see an increase in the risk of side-effects. Hence, a lower dose may be recommended.
The safety and effectiveness of using this medicine in children has not been established. It is not known whether Safetelmi is safe or effective in children.
Limit drinking alcohol with Safetelmi.
Your doctor may require that certain tests be performed before using Safetelmi Tablet. The doctor may ask you to have blood pressure test. Measurement of blood pressure is needed when using Safetelmi for heart and blood vessel disease.
Medicines may be given for uses other than those listed in the medicine guide. Do not use Safetelmi Tablet for symptoms for which it was not prescribed. Do not give Safetelmi Tablet to others who may have similar symptoms as you. Self-medication can cause harm.
Store Safetelmi Tablet 15°C-30°C (59°F-86°F), and away from moisture. Keep this medicine away from children and pets.

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How to take Safetelmi

Your dose and how often you take Safetelmi will depend on the following factors:
  • patient's health
  • the health of the patient's liver
  • the health of the patient's kidneys
  • medicines recommended by the doctor
  • any other medicines being used
  • herbal supplements in use
  • response to the medicine

Safetelmi Dosage

Dosage for high blood pressure

Adult
  • Initial: 40 mg once a day
  • Maximum: 80 mg once a day

Dosage for heart diseases risk reduction

Adult
  • Recommended: 80 mg once a day
  • Initial: 80 mg once a day

Minimum Age

18 years

Forms

Tablet
Strength: 20 mg, 40 mg, and 80 mg

Missed Dose

A missed dose should be taken as early as you remember it. However, if the time for the next dose is almost there, then the missed dose should be skipped, and the regular dosing schedule should be continued. Avoid taking a repeated dose to make up for a missed dose.

Overdose

What to do if you overdose on Safetelmi?
In case, symptoms of low blood pressure occur on using this drug, supportive treatment should be started.
Symptoms of an overdose of Safetelmi
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
If you think you have overdosed on Safetelmi Tablet, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Safetelmi

Before you use Safetelmi, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information.
Before you use Safetelmi Tablet, tell your doctor of your medical history including damage in the major blood vessels of the heart (coronary artery disease), circulatory condition in which narrowed blood vessels reduce the flow of blood to the limbs (peripheral arterial disease), stroke, stroke-like attack lasting for a short time (transient ischemic attack), low levels of blood sugar (diabetes), condition when bile cannot flow from the liver to the gallbladder and small intestine (bile duct blockage), kidney disease, or liver disease. Before having any surgery, discuss with your doctor and dentist about medicines you use including prescription medicines, non-prescription medicines, and herbal supplements.
The use of Safetelmi Tablet may change potassium levels. The level of potassium in the blood rises in patients on treatment with Safetelmi, particularly who have kidney failure, heart failure, patients on kidney replacement therapy, or on potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes.
Safetelmi Tablet is not safe for use in women who are pregnant. If you are pregnant or planning to become pregnant, you should discuss the impact on the fetus with your doctor before you start using this medicine. Safetelmi causes injury and fatality to an unborn baby when it is given to a pregnant woman. Consult with your doctor on the use of Safetelmi Tablet during breastfeeding. A patient should talk with their doctor if they are planning to breastfeed, as it is not known whether Safetelmi passes into breast milk. Safetelmi Tablet may impact fertility in women. If you are trying to conceive, discuss with your doctor on the use of this medicine. If you get pregnant, discontinue the use of Safetelmi as soon as possible.
Safetelmi can make you feel sleepy. Be careful, especially while driving, while using heavy machinery, or when doing any activity that needs you to be completely alert. The consumption of alcohol with Safetelmi can worsen the sleepiness.

What precautions should be taken during Pregnancy and Nursing, and administering Safetelmi to Children or the Older Adults?

Pregnant Women

Contraindication
Warning: Safetelmi causes injury and fatality to an unborn baby when it is given to a pregnant woman.

Breastfeeding

Management or monitoring precaution
Warning: A patient should talk with their doctor if they are planning to breastfeed, as it is not known whether Safetelmi passes into breast milk.

Younger Adults Population

No Known Risk
Warning: Effectiveness and safety in children <18 years age have not been studied.

Older Adults Population

Possibly safe
Warning: There is no overall difference in safety and efficacy compared to younger patients. Greater sensitivity of older individuals cannot be defined.

Safetelmi Side-effects

The following side-effects may commonly occur when using Safetelmi Tablet. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
Rarely, the use of Safetelmi Tablet may cause the following side-effects:
  • abnormal sensation in the body
  • abnormal vision
  • alteration in the sense of taste
  • backflow of the stomach content (gastroesophageal reflux)
  • chest pain
  • coughing
  • dependent swelling
  • dizziness
  • dry mouth
  • earache
  • fainting
  • fatigue
  • feeling of discomfort
  • flushing
  • gas formation
  • headache
  • hives
  • inability to maintain an erection of the penis (erectile dysfunction)
  • increased sweating
  • indigestion (dyspepsia)
  • inflammation of the conjunctiva
  • inflammation of the mucous membrane inside the nose (rhinitis)
  • insomnia
  • involuntary muscle contractions
  • joint pain
  • leg cramps
  • leg pain
  • leg swelling
  • lowering of blood pressure when you stand up from a sitting position
  • muscle pain
  • nausea
  • nervousness
  • pain
  • pain in extremity
  • peripheral swelling
  • rapid or abnormal heartbeat
  • reduced sense of touch (hypoesthesia)
  • ringing in the ears
  • severe itching
  • severe pain, redness and tenderness in joints (gout)
  • stomach pain
  • toothache
  • vertigo
  • weakness
The following severe side-effects may also occur when using Safetelmi Tablet:
  • heart disorders
    Symptoms: reduced blood flow to the heart (angina pectoris), increased heartbeat, irregular heart rhythm, decreased heartbeat lowered blood pressure by standing from the sitting position
    Close monitoring of blood pressure should be done. Appropriate adjustment of medicines that lower the blood pressure may be compulsory.
  • stomach and intestinal disorders
    Symptoms: constipation, gastritis, vomiting, swollen and inflamed veins in the rectum (hemorrhoids), intestinal infection (gastroenteritis), inflammation of the small intestine (enteritis) diarrhea
  • psychiatric disorders
  • respiratory system disorders
    Symptoms: asthma, inflammation of the lining of bronchial tubes (bronchitis), inflammation of the mucous membrane inside the nose (rhinitis), difficulty in breathing nosebleed (epistaxis)
  • eye, ear and labyrinth disorders
    Symptoms: urge to urinate multiple times (micturition frequency) inflammation of the bladder (cystitis)
  • Immune system disorders
    Symptoms: a life-threatening allergic reaction (anaphylactic reaction), allergic reaction fever
  • brain disorders
    Symptoms: migraine drowsiness
  • metabolic disorders (possibly fatal)
    Symptoms: high amounts of cholesterol in the blood (hypercholesterolemia), diabetes mellitus high potassium level
  • infections and infestations (an infection causing injury to its own tissues (sepsis) which can be possibly fatal)
    Symptoms: infection, fungal infection, pus (abscess), inflammatory diseases of the middle ear (otitis media), inflammation of the pharynx (pharyngitis) swelling of the tissue lining the sinuses (sinusitis)
  • skin and subcutaneous tissue disorders
    Symptoms: rash, swelling of the lower layer of the skin, redness of the skin (erythema) severe skin reaction by the drug
Your doctor has prescribed Safetelmi Tablet because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious side-effects. This page does not list all possible side-effects of Safetelmi Tablet.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Side-effects and Allergic Reactions of Safetelmi by Severity and Frequency

Common Side-effects

Following are the common side-effects of this medicine:

Infrequent and Rare Side-effects

Following are the infrequent and rare side-effects of this medicine:

Severe Side-effects

Following are the severe side-effects of this medicine:

Serious Allergic Reactions

Following are the symptoms of serious allergic reactions to this medicine:
  • anaphylactic reaction
  • rash
  • severe allergic reaction
  • swelling of the lower layer of the skin
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Excessive production of the hormone aldosterone from the adrenal glands (primary aldosteronism)

The patients who are on treatment with Safetelmi and who have primary aldosteronism are not responsive to treatment with medicinal products which act through blockade of the renin-angiotensin system. The use of Safetelmi in such patients is not recommended.

Reduction in volume of extracellular fluid (intravascular hypovolemia)

The patients after taking the first dose of Safetelmi may experience symptomatic reduced blood pressure who are volume and sodium depleted by therapy with diuretics, restriction of salt in diet, diarrhea, or vomiting. These conditions in such patients should be treated before starting the treatment with Safetelmi. Volume and sodium loss should be corrected before giving Safetelmi.

Patients with kidney failure and kidney transplantation

The use of Safetelmi in patients who have abnormal functioning of kidneys, frequent monitoring of potassium and creatinine levels in the blood is recommended. The information about the use of Safetelmi in patients with kidney transplantation is not available.

High blood pressure caused by the kidney response to narrowing of the arteries that supply the kidneys

The patients in whom narrowing of one of the arteries of kidneys (bilateral kidney artery stenosis or stenosis of the artery to a single functioning of kidneys) are at an increased risk of severe low blood pressure and kidney insufficiency who are being treated with medicines that affect the renin-angiotensin-aldosterone system.

Dual blockade of the renin-angiotensin-aldosterone system

Patients who are undergoing therapy with renin-angiotensin system blockers are at an increased risk to experience changes in the functioning of kidneys including kidney failure. These patients may suffer from dual blockade of the renin-angiotensin-aldosterone system by adding an ACE-inhibitor to an angiotensin II receptor blocker, and therefore, such patients should be closely monitored of the functioning of kidneys. Patients taking the combination of Safetelmi with ramipril did not obtain any extra advantage as compared to those who received monotherapy but experienced an increased incidence of kidney dysfunctioning compared with groups receiving Safetelmi alone or ramipril alone. Such patients should not use Safetelmi and ramipril in combination.

Kidney dysfunction

Patients with kidney dysfunction and heart problems and who are on treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers are at an increased risk when using Safetelmi. The use of angiotensin-converting enzyme (ACE) blockers and angiotensin receptor blockers in such patients have been related to decreased production of urine, abnormally high levels of nitrogen-containing compounds (azotemia), acute kidney failure, and fatalities. Studies with ACE inhibitors in patients suffering from narrowing of one of the arteries of kidneys (unilateral or bilateral kidney artery stenosis), increases in the level of creatinine in blood or blood urea nitrogen have been observed. In such patients, as a result of blockade of the renin-angiotensin-aldosterone system, the changes in the functioning of kidneys in susceptible individuals should be predicted.

Liver dysfunction

Patients who have biliary obstructive disorders or liver dysfunctioning are at an increased risk to have reduced clearance because major amounts of Safetelmi are cleared by biliary excretion. In such patients, the therapy with Safetelmi should be started at low doses and the dose should be increased slowly.

High levels of potassium in the blood

Patients who are on treatment with angiotensin receptor blockers, particularly who have kidney dysfunctioning, heart failure, who are on kidney replacement therapy, or potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics, or other drugs that increase the levels of potassium are at an increased risk when using this medicine. In such patients, consideration of determination of blood levels of electrolytes should be done to detect the possible electrolyte imbalances, particularly in patients who are at risk.

Low blood pressure

Patients who are on treatment with diuretics with an activated renin-angiotensin system are at an increased risk to experience symptomatic low blood pressure after the therapy with Safetelmi has been started. Such patients should be advised to correct this condition before the beginning of treatment with Safetelmi or start the treatment under closed monitoring with a low dose. If low blood pressure occurs, the patient should be made to lie down and, if necessary, should be given an intravenous infusion with normal saline.

Pregnancy

Patients who become pregnant during the second and third trimesters while using this medicine are at an increased risk because the medicines acting on the renin-angiotensin system can result in harmful effects on the fetus as well as can result in the fatality of the unborn baby (fetus). Pregnant women who take Safetelmi may pose a risk of low blood pressure, skull hypoplasia, failure of the kidneys to produce urine (anuria), reversible or irreversible kidney failure, and can even result in fatalities in the fetus or an unborn child. There may also be a risk of deficiency of amniotic fluid (oligohydramnios) that may result from decreased functioning of kidneys of an unborn child; oligohydramnios has also been related to shortening of muscles of the unborn (fetal limb contractures), deformity in the growth of facial bones (craniofacial deformation), and underdevelopment of lungs. Other conditions reported are prematurity and a condition during which a baby does not grow to a healthy weight (intrauterine growth retardation). Such patients should discontinue the use of Safetelmi as soon as pregnancy is detected.

Narrowing of large blood vessel and abnormal thickening of the heart muscles (aortic and mitral valve stenosis and obstructive hypertrophic cardiomyopathy)

Special caution should be used in patients who are suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.

Patients with high blood sugar on treatment with insulin or agents that lower blood sugar level

The patients with high levels of sugar in blood who are on treatment with insulin or blood sugar lowering agents in combination with Safetelmi are at an increased risk to suffer from low blood sugar. Such patients should undergo regular monitoring of blood sugar levels and adjustment of the dose of insulin or antidiabetic agent may also be required.

Patients with a family history of absorbing fructose (fructose intolerance)

Safetelmi contains sorbitol, therefore patients who have a family history of fructose intolerance should not use Safetelmi.

Different race

Angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists such as Safetelmi are less effective in lowering the blood pressure in black people than in non-blacks due to the reason that black people have low-renin states.

Interactions with Safetelmi

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
Safetelmi Tablet interacts with non-steroidal anti-inflammatory agents along with selective cyclooxygenase-2 inhibitors (COX-2 Inhibitors), which are used to relieve pain and inflammatory conditions. The elderly patients, volume-depleted (patients on diuretic therapy), or with altered functioning of kidneys, a combination of NSAIDs along with Safetelmi may result in abnormal functioning of kidneys including acute kidney failure. These effects are usually reversible. NSAIDs may reduce the blood pressure lowering effect of Safetelmi. Monitoring of functioning of kidneys frequently in patients receiving Safetelmi and NSAID therapy is required.
There may be an interaction of Safetelmi with lithium, which is used for the treatment of depressive disorders. The use of Safetelmi in combination with lithium has resulted in high levels of lithium in the blood and therefore, has resulted in lithium poisoning. Monitoring of lithium levels in the blood should be considered during the use of these drugs together.
Safetelmi Tablet may interact with digoxin, which is used for the treatment of various heart problems. Safetelmi given in combination with digoxin has resulted in increased levels of digoxin in the blood. The levels of digoxin should be monitored while starting, adjusting, and stopping Safetelmi so that the levels of digoxin are within the range above which side-effects begin to occur.
Your doctor's guidelines may need to be followed while taking this medicine along with potassium-sparing diuretics, which are used in combination with other drugs to treat high blood pressure. Safetelmi is responsible for reducing the diuretic induced loss of potassium. Potassium-sparing diuretics such as spirinolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may result in an increase in potassium levels in the blood. The use of Safetelmi in combination with potassium-sparing diuretics should be done very cautiously and the levels of potassium in the blood should be monitored frequently.
Special instructions need to be followed while taking this medicine along with ramipril, which is used to treat high blood pressure and heart failure. When Safetelmi is given in combination with ramipril, the maximum amount of the drug in the blood (Cmax), as well as exposure of the drug to the body (AUC) of ramipril and its metabolite ramiprilat is increased. On the other hand, the amount of Safetelmi in the body is decreased. The increased efficiency of medicine may be observed due to the additive effects of ramipril and its metabolite ramiprilat along with Safetelmi. The use of Safetelmi in combination with ramipril is not recommended.
Your doctor's guidelines may need to be followed while taking this medicine along with alcohol; barbiturates, which are used to treat anxiety disorders; narcotics, which are used to treat severe pain, and antidepressants, which are used to treat depressive states. The use of Safetelmi in combination with these drugs worsens orthostatic low blood pressure, which is the reduction in blood pressure while standing.
Special instructions need to be followed while taking this medicine along with baclofen, which is used as a central nervous system depressant and amifostine, which is used to reduce side-effects of cancer treating drugs. The use of baclofen and amifostine in combination with Safetelmi and other blood pressure lowering agents may enhance the blood pressure lowering effect of Safetelmi.
Safetelmi Tablet interacts with corticosteroids, injection route, which is used for relieving inflammatory conditions. When Safetelmi is used in combination with corticosteroids, the blood pressure lowering effect of Safetelmi is reduced.
There may be an interaction of Safetelmi with other blood pressure lowering agents such as ACE-blockers, angiotensin II receptor blockers or aliskiren. When Safetelmi is used in combination with other blood pressure lowering agents, the blood pressure lowering effect of Safetelmi is enhanced.
Safetelmi Tablet may interact with diuretics such as thiazide, which increases the production of urine. The treatment with a high dose of diuretics such as furosemide and hydrochlorothiazide may result in depletion of volume and risk of low blood pressure when treatment with Safetelmi is started.
This page does not contain all the possible interactions of Safetelmi Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Interactions of Safetelmi by Severity

Severe

The following medicines are usually not to be taken together without consulting with your doctor or pharmacist.

Serious

The following medicines may interact when taken together and can cause harmful effects in the body. Please consult with your doctor or pharmacist before taking these medicines together.

Moderate

The following medicines may interact when taken together and can increase your risk of harmful effects. Please consult with your doctor or pharmacist before taking these medicines together.

When should Safetelmi be not used?

Allergic reaction to Safetelmi

The use of Safetelmi is not recommended in patients who are allergic to Safetelmi.

Use in pregnancy

The use of Safetelmi should not be considered in women who are at the second and third trimester of their pregnancy. The use of Safetelmi during the second and third trimesters has been associated with damaging effects on the unborn baby including, decreased functioning of kidneys, deficiency of amniotic fluid in pregnancy, problems in skull development and damaging effects on the newborns (kidney failure, low blood pressure, and high level of potassium in blood).

Blockade of duct carrying bile from the liver to the gallbladder (biliary obstructive disorders)

The use of Safetelmi should not be considered in patients who have biliary obstructive disorders. The use of Safetelmi is not recommended for patients with blockage in the flow of bile from the liver (cholestasis), biliary obstructive disorders or severe liver failure because Safetelmi is mostly excreted with the bile. Such patients are at a risk to develop reduced liver clearance for Safetelmi. The use of Safetelmi should be done cautiously in patients with mild to moderate liver problems.

Liver damage

The use of Safetelmi should not be considered in patients with liver failure. The use of Safetelmi is not recommended for patients with blockage in the flow of bile from the liver (cholestasis), biliary obstructive disorders or severe liver failure because Safetelmi is mostly excreted with the bile. Such patients are at a risk to develop reduced liver clearance for Safetelmi. The use of Safetelmi should be done cautiously in patients with mild to moderate liver problems.

Products containing aliskiren

The use of Safetelmi in combination with products containing aliskiren is not recommended in patients with high blood sugar or kidney failure.

Sorbitol

Since Safetelmi contains sorbitol, therefore the patients with the problems of the family history of absorbing sugar (fructose intolerance) should not take Safetelmi.

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Safetelmi is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.
This page provides information for Safetelmi Tablet .
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