Ambrisentan Cipla 5 mg/10 mg Film-Coated Tablets

AMBRISENTAN CIPLA contains the active substance ambrisentan. It belongs to a group of medicines called other antihypertensives (used to treat high blood pressure). It is used to treat pulmonary arterial hypertension (PAH) in adults. PAH is high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. In people with PAH, these arteries get narrower, so the heart must work harder to pump blood through them. This causes people to feel tired, dizzy, and short of breath. AMBRISENTAN CIPLA widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood pressure and relieves the symptoms. AMBRISENTAN CIPLA may also be used in combination with other medicines used to treat PAH.

Do not take AMBRISENTAN CIPLA if:

• you are allergic to ambrisentan, soya, or any of the other ingredients of this medicine (as listed in section 6)
• you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contraception). Please read the information under ‘Pregnancy’
• you are breast feeding. Read the information under ‘Breast - feeding’
• you have liver disease. Talk to your doctor, who will decide whether this medicine is suitable for you
• if you have scarring of the lungs, of unknown cause (idiopathic pulmonary fibrosis).

Warnings and precautions

Tell your doctor or health care provider before taking AMBRISENTAN CIPLA if:

• you have liver problems
• you have anaemia (a reduced number of red blood cells)
• you have swelling in the hands, ankles or feet caused by fluid (peripheral oedema)
• you have lung disease where the veins in the lungs are blocked (pulmonary veno - occlusive disease).
• you have been told by your doctor that you have an intolerance to some sugars, Your doctor will decide whether AMBRISENTAN CIPLA is suitable for you.

You will need regular blood tests Before you start taking AMBRISENTAN CIPLA, and at regular intervals while you are taking it, your doctor will take blood tests to check:

• whether you have anaemia (a reduced number of red cells)
• whether your liver is working properly. It is important that you have these regular blood tests for as long as you are taking AMBRISENTAN CIPLA.

Signs that your liver may not be working properly include:

• loss of appetite
• feeling sick (nausea)
• being sick (vomiting)
• high temperature (fever)
• pain in your stomach (abdomen)
• yellowing of your skin or the whites of your eyes (jaundice)
• dark - coloured urine
• itching of your skin.

If you notice any of these signs, Tell your doctor immediately.

Children and adolescents

AMBRISENTAN CIPLA is not recommended for children and adolescents aged under 18 years as the safety and effectiveness is not known in this age group.

Other medicines and AMBRISENTAN CIPLA

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Your doctor may need to adjust your dose of AMBRISENTAN CIPLA if you start taking cyclosporine A (a medicine used after transplant or to treat psoriasis). If you are taking rifampicin (an antibiotic used to treat serious infections) your doctor will monitor you when you first start taking AMBRISENTAN CIPLA. If you are taking other medicines used to treat PAH (e.g. iloprost, epoprostenol, sildenafil) your doctor may need to monitor you. Tell your doctor or pharmacist if you are taking any of these medicines.

Do not share medicines prescribed for you with any other person. Always take AMBRISENTAN CIPLA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose of AMBRISENTAN CIPLA is one 5 mg tablet, once a day. Your doctor may decide to increase your dose to 10 mg, once a day. If you take cyclosporine A, do not take more than one 5 mg tablet of AMBRISENTAN CIPLA, once a day. Your doctor will tell you how long your treatment with AMBRISENTAN CIPLA will last. Do not stop treatment early because you feel better. If you have the impression that the effect of AMBRISENTAN CIPLA is too strong or too weak, tell your doctor or pharmacist. It is best to take your tablet at the same time each day. Take tablet with sufficient quantity of water. Swallow tablet whole, with a glass of water, do not split, crush, or chew the tablet. You can take AMBRISENTAN CIPLA with or without food.

Instructions on how to remove tablet from the pack

These tablets come in special packaging to prevent children removing them.

If you take more AMBRISENTAN CIPLA than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you take too many tablets you may be more likely to have side effects, such as headache, flushing, dizziness, nausea (feeling sick), or low blood pressure that could cause light-headedness. Ask your doctor or pharmacist for advice if you take more tablets than prescribed.

If you forget to take AMBRISENTAN CIPLA

If you forget a dose of AMBRISENTAN CIPLA, just take the tablet as soon as you remember, then carry on as before. Do not take two doses at the same time to make up for a forgotten individual dose. If you stop taking AMBRISENTAN CIPLA AMBRISENTAN CIPLA is a treatment that you will need to keep on taking to control your PAH. Do not stop taking AMBRISENTAN CIPLA unless you have agreed this with your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

AMBRISENTAN CIPLA can have side effects. Not all side effects reported for AMBRISENTAN CIPLA are included in this leaflet. Should your general health worsens or if you experience any untoward effects while taking AMBRISENTAN CIPLA, please consult your health care provider for advice. If any of the following happens, stop taking AMBRISENTAN CIPLA and tell your doctor immediately or go to the casualty department at your nearest hospital:

Allergic reactions

This is a common side effect that may affect up to one in 10 people. You may notice a rash or itching and swelling (usually of the face, lips, tongue, or throat), which may cause difficulty in breathing or swallowing.

Swelling (oedema), especially of the ankles and feet

This is a very common side effect that may affect more than one in 10 people.

Heart failure

This is due to the heart not pumping out enough blood, causing shortness of breath, extreme tiredness and swelling in the ankles and legs. This is a common side effect that may affect up to one in 10 people.

Anaemia (reduced number of red blood cells)

This is a blood disorder which can cause tiredness, weakness, shortness of breath, and generally feeling unwell. Sometimes this requires a blood transfusion. This is a very common side effect that may affect more than one in 10 people.

Hypotension (low blood pressure)

This can cause light-headedness. This is a common side effect that may affect up to one in 10 people. Tell your doctor straight away if you get these effects or if they happen suddenly after taking AMBRISENTAN CIPLA. It is important to have regular blood tests, to check for anaemia and that your liver is working properly. Make sure that you have also read the information in section 2 under ‘You will need regular blood tests’ and ‘Signs that your liver may not be working properly’. Tell your doctor if you notice any of the following:

Other side effects include

Frequent side effects:

• headache
• dizziness
• palpitations (fast or irregular heartbeats)
• worsening shortness of breath shortly after starting AMBRISENTAN CIPLA
• a runny or blocked nose, congestion, or pain in the sinuses
• feeling sick (nausea)
• diarrhoea
• feeling tired.

Less frequent side effects:

• blurry or other changes to vision
• fainting
• abnormal blood test results for liver function
• a runny nose
• constipation
• pain in your stomach (abdomen)
• chest pain or discomfort
• flushing (redness of the skin)
• being sick (vomiting)
• feeling weak
• nosebleed
• rash.

Side effects of which Frequency is unknown:

• liver injury
• inflammation of the liver caused by the body’s own defences (autoimmune hepatitis)

These are all serious side effects. You may need urgent medical attention.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 or to Cipla Medpro (Pty) Ltd. by e-mail: [email protected]. By reporting side effects, you can help provide more information on the safety of AMBRISENTAN CIPLA.

Store all medicines out of reach of children. Store at or below 30 °C. Store in the original package / container. Do not use after the expiry date stated on the label. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).