Sacubitril Valsartan 26 mg Film-Coated Tablets

SACUBITRIL VALSARTAN CIPLA contains two active ingredients called sacubitril and valsartan. SACUBITRIL VALSARTAN CIPLA is used in adults as a second line treatment to replace ACE (angiotensin-converting enzyme) inhibitors or ARB’s (angiotensin receptor blockers) to treat heart failure. SACUBITRIL VALSARTAN CIPLA is used together with other medicines that are used to treat heart failure.

Do not take SACUBITRIL VALSARTAN CIPLA:

• If you are hypersensitive (allergic) to sacubitril or valsartan or any of the other ingredients of SACUBITRIL VALSARTAN CIPLA (listed in section 6).
• If you are currently taking any other medicines called ACE (angiotensin converting enzyme) inhibitors (for example enalapril, lisinopril or ramipril). ACE inhibitors are used to treat high blood pressure or heart failure. If you have been taking ACE inhibitors, wait for 36 hours after taking the last dose of these group of medicines before you start taking SACUBITRIL VALSARTAN CIPLA (see Other medicines and SACUBITRIL VALSARTAN CIPLA).
• If there is a known history of you or your family of a reaction called angioedema (swelling of the face, lips, tongue and/or throat, difficulties in breathing) when taking ACE inhibitors or angiotensin receptor blockers (ARB’s) (such as valsartan, telmisartan or irbesartan).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you are pregnant or breastfeeding.
• If you have diabetes or impaired kidney function and you are being treated with a blood pressure lowering medicine containing aliskiren.
• If you are currently taking medication that is used for bipolar disorder, called lithium.
• If you are taking medication that assists with increasing passing of urine to treat high blood pressure (diuretics) but increases potassium levels in the body, such as spironolactone, amiloride and triamterene, and potassium supplements.
• If you are taking a fluoroquinolone (an antibiotic).

If any of the above applies to you, do not take SACUBITRIL VALSARTAN CIPLA and talk to your doctor.

Warnings and precautions

Tell your doctor or health care provider before taking SACUBITRIL VALSARTAN CIPLA:

• If you are being treated with an ACE inhibitor or ARB. SACUBITRIL VALSARTAN CIPLA must not be taken after stopping treatment with ACE inhibitors or ARB’s until after 36 hours from the time of the last dose of ACE inhibitor or ARB.
• If you are being treated with direct renin inhibitors such as aliskiren. SACUBITRIL VALSARTAN CIPLA should not be taken together with aliskiren if you are diabetic and have severe kidney failure.
• If you have low blood pressure or you are taking any other medicines that reduce your blood pressure or if you are vomiting or having diarrhoea. Blood pressure will have to be corrected before the treatment with SACUBITRIL VALSARTAN CIPLA is started.
• Talk to your doctor or pharmacist if you have had kidney disease or if tests have shown problems with your kidneys. Before starting treatment and during treatment, your doctor may order blood tests to monitor how your kidneys work.
• Talk to your doctor if you ever had angioedema (swelling of the face, lips, tongue and/or throat, difficulties in breathing).
• If your doctor has advised that you have renal artery stenosis (a kidney artery is narrowed).
• If you have liver disease.

If any of the above applies to you, tell your doctor, pharmacist or healthcare practitioner before you take SACUBITRIL VALSARTAN CIPLA.

Children and adolescents

Do not give SACUBITRIL VALSARTAN CIPLA to children under the age of 18 years. SACUBITRIL VALSARTAN CIPLA has not been tested in children less than 18 years of age.

Other medicines and SACUBITRIL VALSARTAN CIPLA

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) SACUBITRIL VALSARTAN CIPLA may interact with other medicines. As a result, the amounts of SACUBITRIL VALSARTAN CIPLA or other medicines in your blood may change. This may stop your medicines from working properly or may make any side effects worse.

Do not share medicines prescribed for you with any other person. Always take SACUBITRIL VALSARTAN CIPLA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The target dose is one (1) tablet of SACUBITRIL VALSARTAN 97/103 mg CIPLA twice daily. The recommended starting dose is one (1) tablet of SACUBITRIL VALSARTAN 24/26 mg CIPLA twice daily for patients currently taking low doses of medicines used to treat high blood pressure (ACE inhibitors or ARB’s).

Your doctor will adjust your dose every 3 - 4 weeks you respond well to one (1) tablet of SACUBITRIL VALSARTAN 97/103 mg CIPLA twice daily. Your doctor will need to perform certain tests prior to increasing your dose.

To avoid low blood pressure (hypotension), the recommended starting dose in patients previously using high doses of medicines used to treat high blood pressure (ACE inhibitors or ARB’s), is one (1) tablet of SACUBITRIL VALSARTAN 49/51 mg CIPLA twice daily.

SACUBITRIL VALSARTAN CIPLA must not be started for at least 36 hours after stopping treatment with medicines used to treat high blood pressure (ACE inhibitors or ARB’s) due to the potential risk of swelling of the face, lips, tongue and/or throat, and difficulties in breathing (angioedema).

If you take more SACUBITRIL VALSARTAN CIPLA than you should If you accidentally take more than the recommended dose of SACUBITRIL VALSARTAN CIPLA you may be at increased risk of experiencing possible side effects with this medicine (see section 4). Hypotension (low blood pressure) is the most likely symptom of overdose due to the blood pressure lowering effects of SACUBITRIL VALSARTAN CIPLA. Severe dizziness and/or fainting may be experienced and if this is experienced contact the doctor and lie down.

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take the tablet container with you so that you can easily describe what you have taken.

If you forget to take SACUBITRIL VALSARTAN CIPLA It is important not to miss a dose of SACUBITRIL VALSARTAN CIPLA. It is advisable to take the medication at the same time each day. If you miss a dose, take the next one at the scheduled time. Do not take a double dose to make up for the missed dose.

If you stop taking SACUBITRIL VALSARTAN CIPLA Do not stop taking SACUBITRIL VALSARTAN CIPLA without your doctor’s advice. Stopping treatment with SACUBITRIL VALSARTAN CIPLA may cause your condition to get worse. Talk to your doctor before you stop taking SACUBITRIL VALSARTAN CIPLA for any reason, particularly if you are experiencing any side effects or you have another illness.

If you have any further questions on the use of SACUBITRIL VALSARTAN CIPLA, ask your doctor or pharmacist.

SACUBITRIL VALSARTAN CIPLA can have side effects. Not all side effects reported for SACUBITRIL VALSARTAN CIPLA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SACUBITRIL VALSARTAN CIPLA, please consult your health care provider for advice.

If any of the following happens, stop taking SACUBITRIL VALSARTAN CIPLA and tell your doctor immediately or go to the casualty department at your nearest hospital.

• Allergic reaction such as swelling of the face, lips, tongue and/or throat, which may cause difficulties in swallowing or breathing. These may be signs of angioedema.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to SACUBITRIL VALSARTAN CIPLA. You may need urgent medical attention or hospitalisation.

Other frequent possible side effects that must be reported to the doctor or pharmacist if they become severe:

• Low blood pressure (dizziness, light-headedness).
• High level of potassium in the blood (shown in blood tests).
• Decreased kidney function (kidney impairment).

Tell your doctor if you notice any of the following:

Frequent side effects:

• Cough.
• Dizziness.
• Diarrhoea.
• Low levels of red blood cell (shown in blood tests).
• Headache.
• Acute kidney failure (decreased urination, swelling in your legs, ankles or feet due to fluid retention).
• Weakness.
• Feeling sick (nausea).
• Low blood pressure (dizziness, light-headedness).
• Gastritis (stomach pain, nausea).
• Spinning sensation.
• Low levels of sugar in the blood (shown in blood tests).

Less frequent side effects:

• Dizziness when switching from sitting or lying to standing position.

If any of these side effects get serious tell your doctor. 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, pharmacist 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] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of SACUBITRIL VALSARTAN CIPLA.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from moisture. Store in the original package until required for use. Do not use after the expiry date stated on the package. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).