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Telmisartan/HCT Sandoz® Tablets

Telmisartan and Hydrochlorothiazide


Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Telmisartan/HCT Sandoz®.

It does not contain all available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking this medicine against the benefits it is expected to have for you.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

WHAT TELMISARTAN/HCT SANDOZ® IS USED FOR

This medicine is used to lower high blood pressure (hypertension).

Everyone has blood pressure. This pressure helps your blood move around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm or relaxed.

There are usually no signs of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated, it can lead to serious health problems, including stroke, heart disease and kidney failure.

This medicine contains the active ingredients telmisartan and hydrochlorothiazide. These two active ingredients help to reduce blood pressure in different ways:

  • Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance in the body which causes blood vessels to narrow, thus increasing blood pressure. Telmisartan works by blocking the effect of angiotensin II. When the effect of angiotensin II is blocked, your blood vessels relax and your blood pressure goes down.
  • Hydrochlorothiazide belongs to the group of medicines called diuretics. Diuretics help to reduce the amount of excess fluid in the body by increasing the amount of urine produced. They help with lowering blood pressure particularly when used with other blood pressure lowering medicines.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed Telmisartan/HCT Sandoz® for another reason.

Telmisartan/HCT Sandoz® is not addictive.

This medicine is available only with a doctor's prescription.

BEFORE YOU TAKE TELMISARTAN/HCT SANDOZ®

When you must not take it

Do not take this medicine if you have an allergy to:

  • Telmisartan or hydrochlorothiazide (the two active ingredients), or to any of the other ingredients listed at the end of this leaflet under Product Description
  • Other sulfonamide-derived medicines

Some of the symptoms of an allergic reaction may include:

  • skin rash
  • itchiness
  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips or tongue
  • muscle pain or tenderness or joint pain.

Do not take this medicine if you have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Do not take this medicine if you are pregnant or intend to become pregnant. This medicine is not recommended for use in pregnancy. It may affect your developing baby if you take it during pregnancy.

Do not breast-feed if you are taking this medicine. It is not known if the active ingredients in Telmisartan/HCT Sandoz® pass into breast milk and there is a possibility that your baby may be affected.

Do not give this medicine to a child under the age of 18 years. Safety and effectiveness in children and teenagers up to 18 years of age have not been established.

Do not take this medicine if you have any of the following medical conditions:

  • severe liver disease
  • severe kidney disease
  • cholestasis or biliary obstructive disorders (problem with the flow of bile from the gallbladder)
  • low potassium levels in the blood
  • high calcium levels in the blood
  • diabetes or kidney problems and you are taking aliskiren ( a medicine used to treat high blood pressure).

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have, or have had, any of the following medical conditions:

  • kidney problems
  • liver problems
  • heart problems
  • a condition known as primary hyperaldosteronism (raised aldosterone levels, also known as Conn's syndrome)
  • diabetes
  • gout
  • galactose intolerance
  • a low salt diet
  • recent severe diarrhoea or vomiting
  • asthma
  • systemic lupus erythematosus (a disease affecting the skin, joints and kidney)
  • eye problems.

Tell your doctor if you are following a very low salt diet.

Tell your doctor if you plan to become pregnant or breastfeed.

If you have not told your doctor about any of the above, tell your doctor before you take Telmisartan/HCT Sandoz®.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Telmisartan/HCT Sandoz® may interfere with each other. These include:

  • any other medicines used to treat high blood pressure such as beta-blockers
  • heart medicines such as digoxin, a medicine used to treat heart failure or antiarrhythmic medicines
  • lithium, a medicine used to treat certain mental illnesses
  • other diuretics or fluid tablets medicines used to help the kidneys get rid of salt and water by increasing the amount of urine produced
  • laxatives
  • potassium supplements or potassium-containing salt substitutes
  • medicines or salt substitutes which may increase your potassium levels
  • amphotericin B, a medicine used to treat fungal infections
  • penicillin antibiotics used to treat bacterial infections
  • alcohol
  • sleeping tablets
  • strong pain killing medicines
  • medicines for diabetes (oral tablets or capsules or insulin)
  • powder or granules used to help reduce cholesterol
  • corticosteroid medicines such as prednisolone, cortisone or ACTH
  • aspirin
  • nonsteroidal anti-inflammatory agents (medicines used to relieve pain, swelling and other symptoms of inflammation including arthritis)
  • medicines used to treat gout
  • calcium supplements or medicines containing calcium
  • anticholinergic medicines, which can be used to treat Parkinson's disease, relieve stomach cramps or prevent travel sickness
  • amantadine, a medicine used to treat Parkinson's disease or to prevent influenza
  • medicines used to treat cancer (cytotoxic medicines)

These medicines may be affected by Telmisartan/HCT Sandoz®, or may affect the way it works. Also, other medicines used to treat high blood pressure may have an additive effect with Telmisartan/HCT Sandoz® in lowering your blood pressure. Therefore, you may need different amounts of your medicines or you may need different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking this medicine.

HOW TO TAKE TELMISARTAN/HCT SANDOZ®

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help. Your doctor or pharmacist will tell you how many tablets you will need to take each day. This depends on your condition and whether or not you are taking any other medicines.

How much to take

Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.

Follow the instructions they give you. The usual dose for adults is one Telmisartan/HCT Sandoz® 40/12.5 mg tablet once a day.

If your blood pressure is still too high after 4-8 weeks of starting treatment, your doctor may increase your dose to one Telmisartan/HCT Sandoz® 80/12.5 mg tablet once a day.

If your blood pressure is still not satisfactorily controlled with Telmisartan/HCT Sandoz® 80/12.5 mg, your doctor may increase your dose to one Telmisartan/HCT Sandoz® 80/25 mg tablet once a day.

When to take it

Take your medicine at about the same time each day, either morning or evening. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

You can take your medicine with or without food. It does not matter if you take your medicine before or after food.

How to take it

Swallow the tablet whole with a full glass of water.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

This medicine helps control your condition, but does not cure it. It is important to keep taking your medicine every day even if you feel well.

People who have high blood pressure often feel well and do not notice any signs of this problem.

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting unwanted side effects.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26 or New Zealand 0800 POISON or 0800 764766)) for advice or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Telmisartan/HCT Sandoz®.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include feeling dizzy, light-headed or faint. Your heartbeat may be faster or lower than usual. You may experience dehydration, nausea, drowsiness and muscle spasm.

WHILE YOU ARE TAKING TELMISARTAN/HCT SANDOZ®

Things you must do

If you are about to be started on any new medicine, tell your doctor or pharmacist that you are taking Telmisartan/HCT Sandoz®.

Tell any other doctors, dentists and pharmacists who are treating you that you are taking this medicine.

If you are going to have surgery, tell your surgeon and anaesthetist that you are taking this medicine.

It may affect other medicines used during surgery.

Tell your doctor if, for any reason, you have not used Telmisartan/HCT Sandoz® exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

If you become pregnant while taking this medicine, tell your doctor immediately. You should not take this medicine while you are pregnant.

Things you must not do

Do not take Telmisartan/HCT Sandoz® to treat other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful when driving or operating machinery until you know how Telmisartan/HCT Sandoz® affects you. This medicine may cause sleepiness, dizziness or light-headedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

You may feel dizzy or light-headed when you begin to take Telmisartan/HCT Sandoz®, especially if you are also taking a diuretic (or fluid tablet) or if you are dehydrated.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from a bed or chair, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

If you exercise, or if you sweat, or if the weather is hot, you should drink plenty of water.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Telmisartan/HCT Sandoz®.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • 'flu-like' symptoms
  • fainting, dizziness or spinning sensation
  • a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbing ache (sinusitis)
  • infections of the air passages
  • shortness of breath or difficulty breathing
  • abnormal or blurred vision
  • eye pain
  • back pain
  • changes in heart rhythm or increased heart rate
  • rash or redness or itchiness of skin
  • increased sweating
  • dizziness or light-headedness when you stand up (postural hypotension)
  • stomach pain or discomfort (abdominal pain, dyspepsia, gastritis)
  • wind or excessive gas in the stomach or bowel
  • vomiting
  • diarrhoea or constipation
  • dry mouth
  • pins and needles
  • sleep disturbances or trouble sleeping
  • feeling anxious
  • depression
  • impotence
  • leg pain or cramps in legs
  • aching muscles or aching joints not caused by exercise or muscle spasms
  • chest pain
  • pain
  • liver problems
  • changes in the levels of potassium or sodium or uric acid in your blood (such changes are usually detected by a blood test)

Tell your doctor as soon as possible if you notice any of the following:

Symptoms such as feeling very thirsty, sleepy, sick or vomiting, a dry mouth, general weakness, muscle pain or cramps, a very fast heart rate, may mean that the hydrochlorothiazide part of Telmisartan/HCT Sandoz® is having an excessive effect.

You should tell your doctor if you experience any of these symptoms.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
  • severe and sudden onset of pinkish, itchy swellings on the skin, also called hives or nettle rash
  • developing or worsening of a disease called systemic lupus erythematosus which affects the skin, joints and kidney

The above list includes serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Tell your doctor or pharmacist if you notice anything else that is making you unwell. Other side effects not listed above may also occur in some people.

AFTER TAKING TELMISARTAN/HCT SANDOZ®

Storage

Keep your medicine in the original container.

If you take it out of its original container it may not keep well.

Keep your medicine in a cool, dry place where the temperature stays below 25°C.

Do not store Telmisartan/HCT Sandoz® or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over

PRODUCT DESCRIPTION

What it looks like

Telmisartan/HCT Sandoz® 40mg/12.5mg tablet - red, oval, biconvex film-coated tablet debossed with 40 on one side and with 12.5 on the other side

Telmisartan HCT Sandoz 80mg/12.5mg tablet - white to white off, oval, biconvex film-coated tablet debossed with 80 on one side and with 12.5 on the other side

Telmisartan HCT Sandoz® 80mg/25mg tablet - yellow, oval, biconvex film-coated tablet debossed with 80 on one side and with 25 on the other side.

Available in blister packs of 28 tablets.

Ingredients

Active ingredients:

  • Each Telmisartan/HCT Sandoz® 40mg/12.5mg tablet contains 40mg telmisartan and 12.5mg hydrochlorothiazide.
  • Each Telmisartan/HCT Sandoz® 80mg/12.5mg tablet contains 80mg telmisartan and 12.5mg hydrochlorothiazide.
  • Each Telmisartan/HCT Sandoz® 80mg/25mg tablet contains 80mg telmisartan and 25mg hydrochlorothiazide.

Inactive ingredients:

  • crospovidone
  • meglumine
  • sodium hydroxide
  • povidone
  • lactose monohydrate
  • lactose anhydrous
  • magnesium stearate
  • macrogol poly(vinyl alcohol) grafted copolymer
  • citric acid monohydrate
  • anhydrous colloidal silica
  • iron oxide yellow (in Telmisartan/HCT Sandoz® 40/12.5 mg tablet and Telmisartan/HCT Sandoz® 80/25 mg tablets)
  • iron oxide red (in Telmisartan/HCT Sandoz® 40/12.5 mg tablet)

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 726 369

This leaflet was revised in February 2019.

Australian Register Numbers

Telmisartan/HCT Sandoz® 40mg/12.5mg: AUST R 201356

Telmisartan/HCT Sandoz® 80mg/12.5mg: AUST R 201359

Telmisartan/HCT Sandoz® 80mg/25mg: AUST R 201358

Published by MIMS March 2019

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