Amlotel Tablets

AMLOTEL is used to treat high blood pressure (also known as essential hypertension) in patients using the same components as individual components, or when treatment with amlodipine alone did not lower your blood pressure enough.

Do not take AMLOTEL:

• if you are allergic to telmisartan, amlodipine or any of the other ingredients included in AMLOTEL tablets.
• If you are allergic to other medicines of the dihydropyridine type (one type of calcium channel blocker).
• If you are pregnant or breast feeding
• If you have developed swelling and giant wheals on your skin when having previously taken medicines called angiotensin converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARB’s).
• If you have a narrowing of the aortic blood vessel.
• If both blood vessels to the kidneys are narrowed or if you have a single kidney and the blood vessel to the kidney is narrowed.
• If you suffer from severe liver problems.
• If you suffer from biliary obstruction (a problem with the drainage of the bile from the liver and gall bladder).
• If you suffer from porphyria.
• If you are currently taking lithium or potassium sparing water tablets
• Do not take AMLOTEL if you are pregnant, are considering becoming pregnant or are breast-feeding. A switch to a suitable alternative treatment should be carried out in advance of planned pregnancy containing spironolactone, triamterene or amiloride.
• If you suffer from low heart output because of a serious heart problem.
• If you suffer from severe renal impairment.
• If you are currently taking aliskiren-containing products

Take special care with AMLOTEL and tell your doctor:

• If you suffer from kidney disease or have ever had a kidney transplant.
• If you suffer from liver problems.
• If you have heart problems.
• If you are planning to become pregnant.
• If you already take a medicine called an angiotensin converting enzyme inhibitor (ACE-I).
• If you have been told that you have raised aldosterone levels (water and salt retention I the body along with imbalance of various blood minerals).
• If you have low blood pressure (hypotension), which is likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (“water tablets”), low-salt diet, diarrhea, or vomiting.
• If you have high potassium levels in your blood or use salt substitutes that contain potassium.

In case of surgery or anaesthesia, you should tell your doctor that you are taking AMLOTEL. The use of AMLOTEL in children and adolescents up to the age of 18 years is not recommended.

Do not share medicines prescribed for you with any other person. Always take AMLOTEL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose of AMLOTEL is one tablet per day. Try to take the tablet at the same time each day.

Remove your AMLOTEL tablet from the blister only immediately prior to intake. You can take AMLOTEL with or without food. The tablets should be swallowed with some water. It is important that you take AMLOTEL every day until your doctor tells you otherwise. If you have the impression that the effect of AMLOTEL is too strong or too weak, talk to your doctor or pharmacist.

If your liver is not working properly, the usual dose should not exceed AMLOTEL 40/5 mg or AMLOTEL 40/10 mg once daily.

If you take more AMLOTEL than you should: In the event of overdosage or accidental intake, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take AMLOTEL: If you forget to take a dose, do not worry. Take it as soon as you remember on the same day. If you do not take your tablet on that same day, take your normal dose on the next day. Do not take a double dose to make up for forgotten individual doses.

AMLOTEL can have side effects. Not all side-effects reported for AMLOTEL are included in this leaflet. Should your general health worsen while taking AMLOTEL, please consult your doctor, pharmacist, or other healthcare professional for advice. If you have any of the following happens, stop taking AMLOTEL and tell your doctor immediately or go to the casualty department at your nearest hospital.

Frequent:

• Dizziness, swelling of the ankles

Less frequent:

• Allergic reaction (e.g. rash, difficulty breathing, wheezing, swelling of the face or low blood pressure),
• Infections
• Low blood pressure (hypotension),
• Dizziness on standing up (orthostatic hypotension),
• Weakness,
• Swelling,
• Depression,
• Feeling anxious
• Fainting
• Rash, severe skin reactions,
• Itching,
• Feeling unwell
• Yellowing of the skin (jaundice),

These are all very serious side effects. If you have them, you may have had a serious reaction to AMLOTEL. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Store at or below 30 °C in the original package in order to protect from light and moisture. Keep out of reach of children. Remove your AMLOTEL tablet from the blister only immediately prior to intake. Do not take AMLOTEL after the expiry date stated on the blister strips and carton. The expiry date refers to the last day of that month. Return all unused or expired medicines to your pharmacist for safe disposal. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).