Twynsta (Telmisartan/Amlodipine)

Serious Warnings and Precautions—Pregnancy

TWYNSTA should not be used during pregnancy. If you discover that you are pregnant while taking TWYNSTA, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.

BEFORE you use TWYNSTA talk to your doctor or pharmacist if you:

• Have experienced an allergic reaction to any drug used to lower blood pressure.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Swelling of your legs.
• Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
• Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with TWYNSTA is not recommended.
• Are taking an angiotensin-converting-enzyme inhibitor (ACEI).
• Have angina, narrowing of a heart valve or blood vessel, heart or blood vessel disease.
• Have diabetes mellitus, liver or kidney disease.
• Are on dialysis or have a kidney transplant.
• Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
• Are on a low-salt diet.
• Are taking a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill” that makes your body keep potassium).
• Are less than 18 years old.

In case of surgery or anaesthesia, you should tell your doctor that you are taking TWYNSTA.

Driving and using machines:

Before you perform tasks which may require special attention, wait until you know how you respond to TWYNSTA. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

Side effects may include:

• dizziness, vertigo (feeling of spinning)
• drowsiness, insomnia, fatigue
• urge to urinate during the night
• rash, eczema, redness of skin, skin eruptions, itching, hives (urticaria), scaling of the skin (exfoliative dermatitis), increased sweating, drug rash, hair loss, skin discolouration, photosensitivity reaction
• diarrhea, vomiting, constipation, nausea, upset stomach, abdominal pain, flatulence, change of bowel habit
• taste abnormalities, enlarged gums
• dry mouth
• headache, migraine, anxiety, mood changes, ringing in the ears
• sleepiness, sleeplessness, tiredness
• back or leg pain, muscle cramps, joint pain, muscle spasms
• visual disturbance
• upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), flu-like illness, cough, sneezing, runny nose, shortness of breath
• inability to obtain an erection
• enlarging of male breasts
• weight increased, weight decreased.

If any of these affects you severely, tell your doctor, nurse or pharmacist.

TWYNSTA can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with TWYNSTA:

• Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”);
• Blood pressure lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. Rasilez), or angiotensin-converting-enzyme inhibitors (ACEIs);
• Clarithromycin, an antibiotic used to treat infections;
• Lithium used to treat mood bipolar disease;
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ASA (Aspirin), ibuprofen, naproxen, and celecoxib;
• Corticosteroids taken by mouth or injection;
• Digoxin to treat heart conditions;
• Warfarin used to prevent blood clots (blood thinner);
• Anticonvulsant agents. Examples include carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone;
• Rifampicin, an antibiotic used to treat infections;
• Medicines used to treat HIV/AIDS. An example is ritonavir;
• Medicines used to treat fungal infections. Examples include ketoconazole, itraconazole;
• Atorvastatin and Simvastatin used to lower cholesterol;
• Sildenafil (Viagra);
• St. John's wort;
• Immunosuppressants, such as ciclosporin and tacrolimus.

Lower than normal blood pressure may occur when TWYNSTA is given with the following:

• alcohol;
• antidepressants;
• barbiturates (sleeping pills);
• narcotics (strong pain medications);
• nitroglycerin or other nitrates;

Take TWYNSTA exactly as prescribed. It is recommended to swallow your dose whole with water at about the same time everyday, preferably in the morning.

Take TWYNSTA with or without food, but it should be taken the same way each day.

Remove your TWYNSTA tablet from the blister just prior to intake.

Usual adult dose:

The usual dose of TWYNSTA is one tablet once a day.

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

Overdose:

If you think you have taken too much TWYNSTA contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.

Missed dose:

If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.