VALSARTAN DURBAN 320 mg FILM-COATED TABLETS

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren

Your doctor may need to check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.

See also the information under the heading “Do not take Valsartan Durban”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valsartan Durban. Your doctor will decide if you need additional treatment. Do not stop taking Valsartan Durban on your own.

You must inform your doctor if you think you are (or might become) pregnant. Valsartan Durban is not recommended at the start of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy (see the section on pregnancy)

Other medicines and Valsartan Durban

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effect of the treatment may be influenced if you take Valsartan Durban with other medicines. It may be necessary to change the dose, take other precautions, or in some cases, stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines that lower blood pressure, especially diuretics, ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also the information under the headings “Do not take Valsartan Durban” and “Warnings and precautions”).
• medicines that increase the amount of potassium in your blood, such as potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, and heparin.
• certain types of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (of the rifampicin group), a medicine used to prevent rejection in a transplant (ciclosporin), or an antiretroviral medicine used to treat HIV/AIDS (ritonavir). These medicines may increase the effect of Valsartan Durban.
• lithium, a medicine used to treat some psychiatric diseases.

Also:

heart attack, it is not recommended to combine with ACE inhibitors(a medication for treating a heart attack).heart failure, it is not recommended to combine with an ACE inhibitor and specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may need to adjust your dose and/or take other precautions.

Taking Valsartan Durban with food and drinks

You can take Valsartan Durban with or without food.

Pregnancy, breast-feeding, and fertility

• You must inform your doctor if you think you are (or might become) pregnant.Normally, your doctor will advise you to stop taking Valsartan Durban before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of valsartan. Valsartan Durban is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

• Tell your doctor if you are breast-feeding or about to start breast-feeding.Valsartan Durban is not recommended for breast-feeding women, and your doctor may choose another treatment if you want to breast-feed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or carrying out other activities that require concentration, make sure you know how valsartan affects you. Like many other medicines used to treat high blood pressure, in rare cases, Valsartan Durban can cause dizziness and affect your ability to concentrate.

3. How to take Valsartan Durban

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. People with high blood pressure often do not notice any symptoms. Many may feel fine. For this reason, it is very important that you attend your medical appointments even if you feel well.

Adult patients with high blood pressure:The recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (e.g., 160 mg or 320 mg). Valsartan Durban can also be given with another medicine (e.g., a diuretic).

Use in children and adolescents (from 6 to less than 18 years of age) with high blood pressure:In patients who weigh less than 35 kg, the recommended initial dose is 40 mg of valsartan once daily. In patients who weigh 35 kg or more, the recommended initial dose is 80 mg of valsartan once daily.

In some cases, your doctor may prescribe higher doses (the dose can be increased to 160 mg and up to a maximum of 320 mg).

You can take Valsartan Durban with or without food. Swallow Valsartan Durban with a glass of water. Take Valsartan Durban at approximately the same time each day.

If you take more Valsartan Durban than you should

If you notice a strong dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

If you forget to take Valsartan Durban

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Valsartan Durban

Stopping your treatment with Valsartan Durban may cause your disease to worsen. Do not stop taking your medicine unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and may need immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as

• swelling of the face, lips, tongue, or throat
• difficulty breathing or swallowing
• rash, itching

If you experience any of these symptoms, stop taking Valsartan Durban and contact your doctor immediately (see also section 2 “Warnings and precautions”)

Other side effects are:

Common(may affect up to 1 in 10 people):

• dizziness
• low blood pressure with or without symptoms, such as dizziness and fainting when standing up
• worsening of kidney function (signs of kidney failure)

Uncommon(may affect up to 1 in 100 people):

• angioedema (see the section “some symptoms that may be serious and require immediate medical attention”)

• sudden loss of consciousness (syncope)
• feeling that everything is spinning (vertigo)
• severe worsening of kidney function (signs of acute kidney failure)
• muscle spasms, abnormal heart rhythm (signs of hyperkalemia)
• shortness of breath, difficulty breathing when lying down, swelling of feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhea
• fatigue
• weakness

• Rare(may affect up to 1 in 10,000 people)

• Intestinal angioedema: inflammation of the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known(cannot be estimated from the available data):

• blistering of the skin (sign of bullous dermatitis)
  • allergic reactions may occur, such as rash, itching, or hives; symptoms of fever, pain, and swelling of joints, muscle pain, swelling of lymph nodes, or flu-like symptoms (signs of serum sickness)

• purple spots on the skin, fever, itching (signs of vasculitis)
• bleeding or bruising (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, known as neutropenia)
• decrease in hemoglobin and hematocrit levels in the blood (which can lead to anemia in severe cases)
• increase in potassium levels in the blood (which can cause muscle spasms and abnormal heart rhythm in severe cases)
• increase in liver function test values (which can indicate liver damage), including an increase in bilirubin levels in the blood (which can cause yellowing of the skin and eyes in severe cases)
• increase in blood urea nitrogen and serum creatinine levels (which can indicate abnormal kidney function)
• low sodium levels in the blood (which can cause fatigue, confusion, muscle twitching, or seizures in severe cases)

The frequency of some side effects may vary depending on your disease. For example, side effects such as dizziness and worsening of kidney function were observed less frequently in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

Side effects in children and adolescents are similar to those observed in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartan Durban

Store at a temperature below 25°C in the original package. Protect from moisture.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of the month shown.

Do not take any Valsartan Durban tablet if you notice that the packaging is damaged or shows signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Valsartan Durban

• The active substance is valsartan.
• The other ingredients are microcrystalline cellulose, crospovidone (type A), colloidal anhydrous silica, magnesium stearate.
• The tablet coating contains hypromellose 6 cp (E464), titanium dioxide (E171), Macrogol 8000, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and packaging content

Light red colored film-coated tablets, scored, oval and biconvex, with the engraving “L” and “13” on both sides of the score on one face and smooth on the other face (approximate size: 13 x 6.2 mm). The score is only to allow breaking and to facilitate swallowing, but not to divide into equal doses.

The tablets are presented in blister packs of 7, 14, 28, 56, 98 and 280 film-coated tablets.

Some pack sizes may not be marketed.

Marketing authorization holder

Laboratorios Francisco Durbán S.A.

Polígono Ind. La Redonda, c/ IX, nº 2

04710 El Ejido ALMERÍA

Spain

Manufacturer

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue, Wynyard,

Billingham, TS22 5TB

United Kingdom

or

Netpharmalab Consulting Services

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid

Spain

or

Synoptis Industrial Sp. z.o.o.

Nl. Rabowicka 15

62-020 Swarzedz

Poland

You can request more information about this medication by contacting the marketing authorization holder.

This medication is authorized in the EEA member states with the following names:

Date of the last revision of this leaflet:08/2020

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.