Wamlox

Package leaflet: Information for the patient

Wamlox, 5 mg + 320 mg, film-coated tablets
Wamlox, 10 mg + 320 mg, film-coated tablets
Amlodipinum + Valsartanum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Wamlox is and what it is used for
2. Important information before taking Wamlox
3. How to take Wamlox
4. Possible side effects
5. How to store Wamlox
6. Contents of the pack and other information

1. What Wamlox is and what it is used for
Wamlox is used to treat high blood pressure in patients who are already taking amlodipine and valsartan at the same doses as in the combination product, instead of taking separate medicines.
Wamlox contains two active substances: amlodipine and valsartan. Both substances help control high blood pressure.

• Amlodipine belongs to a group of substances called calcium channel blockers. It prevents calcium ions from entering the walls of blood vessels, which inhibits blood vessel constriction.
• Valsartan belongs to a group of substances called angiotensin II receptor antagonists. Angiotensin II is produced in the human body and causes blood vessel constriction, increasing blood pressure. Valsartan blocks the action of angiotensin II.

This means that both substances inhibit blood vessel constriction. As a result, blood vessels relax and blood pressure decreases.

2. Important information before taking Wamlox

When not to take Wamlox

• if you are allergic to amlodipine or other calcium channel blockers – itching, skin redness or breathing difficulties may occur;
• if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6) – if you suspect you may be allergic, inform your doctor before taking Wamlox;
• if you have severe liver or biliary tract diseases, such as biliary cirrhosis or cholestasis;
• after the third month of pregnancy (you should also avoid using Wamlox in early pregnancy; see section “Pregnancy”);
• if you have significantly low blood pressure (hypotension);
• if you have aortic valve stenosis or cardiogenic shock (a condition in which the heart cannot deliver sufficient blood to the body’s cells);
• if you have heart failure following a myocardial infarction;
• if you have high blood sugar levels and type 2 diabetes (also called insulin-independent diabetes) or kidney dysfunction and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above apply to you, do not take Wamlox and discuss this with your doctor.
Warnings and precautions
Before starting Wamlox, discuss with your doctor:

• if you have gastrointestinal disorders (vomiting, diarrhoea);
• if you have liver or kidney disease;
• if you have had a kidney transplant or have renal artery stenosis;
• if you have an adrenal gland disorder called primary hyperaldosteronism;
• if you have had heart failure or a previous myocardial infarction – strictly follow your doctor’s recommendations regarding the initial dose; your doctor may also check kidney function;
• if you have heart valve stenosis (aortic or mitral valve stenosis) or thickening of the heart muscle (hypertrophic cardiomyopathy with outflow tract obstruction);
• if you have previously experienced swelling, particularly of the face and throat, while taking other medicines (including ACE inhibitors) – if such symptoms occur, stop taking Wamlox immediately, contact your doctor and never take Wamlox again;
• if you are taking any of the following medicines used to treat high blood pressure:
• ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure and blood levels of electrolytes (e.g. potassium).
If you experience abdominal pain, nausea, vomiting or diarrhoea after taking Wamlox, discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Wamlox on your own.
See also the section “When not to take Wamlox”.
If any of the above apply to you, inform your doctor before taking Wamlox.
Children and adolescents
Wamlox is not recommended for use in children and adolescents (under 18 years of age).
Wamlox and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any you plan to take. Your doctor may need to adjust the dose and/or take other precautions. In some cases, discontinuation of one of the medicines may be necessary. This particularly applies to the following medicines:

• other blood pressure-lowering medicines, such as ACE inhibitors or aliskiren;
• diuretics (also called water tablets, which increase urine output);
• lithium (a medicine used to treat depression);
• potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, and other substances that may increase potassium levels;
• certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors – your doctor may recommend checking kidney function;
• anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St John’s wort (Hypericum perforatum);
• glyceryl trinitrate and other nitrates or other substances that dilate blood vessels;
• medicines used to treat HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
• medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (medicines used for heart conditions);
• simvastatin (a medicine used to reduce high cholesterol levels in the blood);
• dantrolene (administered intravenously in cases of severe temperature disorders);
• medicines used to prevent organ transplant rejection (cyclosporine, tacrolimus);
• sirolimus, temsirolimus and everolimus (medicines used to suppress immune system activity).

Wamlox with food and drink
Patients taking Wamlox should not eat grapefruit or drink grapefruit juice, as both grapefruit and grapefruit juice may increase blood levels of the active substance

• amlodipine, which could lead to unpredictable intensification of the blood pressure-lowering effect of Wamlox.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Your doctor will usually advise stopping Wamlox before planning pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Wamlox is not recommended during early pregnancy (first 3 months) and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used beyond 3 months of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Wamlox is not recommended during breastfeeding. Your doctor may recommend alternative treatment if you wish to breastfeed, especially if the infant is a newborn or premature. Small amounts of amlodipine have been shown to pass into human milk.
Before taking any medicine, consult your doctor or pharmacist.
Driving and using machines
This medicine may cause dizziness, which may impair your ability to concentrate. Therefore, do not drive, operate machinery or perform any other tasks requiring concentration until you know how this medicine affects you.
Wamlox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Wamlox

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor.
This will help achieve the best treatment results and reduce the risk of adverse effects.
The usual dose of Wamlox is 1 tablet per day.

• It is recommended to take the medicine at the same time every day.
• Tablets should be swallowed with a glass of water.
• Wamlox may be taken during meals or independently of meals. Do not take Wamlox together with grapefruit or grapefruit juice.

Depending on the response to treatment, your doctor may recommend a higher or lower dose.
Do not take more than the recommended dose.

Use of Wamlox in elderly patients (aged 65 years and above)
When increasing the dose, your doctor will exercise caution.

Taking more Wamlox than recommended
If too many Wamlox tablets have been taken or if someone else accidentally takes the tablets,
seek immediate medical advice.
Breathing difficulties caused by excess fluid accumulating in the lungs (pulmonary edema) may occur
up to 24–48 hours after taking the medicine.

If a dose of Wamlox is missed
If the patient forgets to take the medicine, it should be taken as soon as possible. The next dose
should be taken at the usual time. However, if it is almost time for the next dose, the missed dose
should be skipped. Do not take a double dose to make up for a missed dose.

Stopping Wamlox
Stopping treatment with Wamlox may cause worsening of the disease. Do not discontinue the medicine
unless advised by your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and require immediate medical attention – severe adverse
reactions have occurred in a few patients (may occur in less than 1 in 1,000 people).
If any of the symptoms listed below occur, you should immediately inform your doctor:

• allergic reaction with symptoms such as rash, itching, swelling of the face, lips or tongue, difficulty breathing, low blood pressure (feeling faint, "emptiness" in the head).

Other possible adverse reactions of Wamlox:
Common (may occur in less than 1 in 10 people): flu-like symptoms; nasal congestion, sore throat and discomfort during swallowing; headache; swelling of arms, hands, legs, ankles or feet; fatigue; asthenia (weakness); redness and feeling of warmth in the face and (or) neck.
Uncommon (may occur in less than 1 in 100 people): central dizziness; nausea and abdominal pain; dryness of the oral mucosa; drowsiness, tingling or numbness in hands or feet; vestibular dizziness, rapid heartbeat, including palpitations; dizziness upon standing; cough; diarrhoea; constipation; skin rash, skin redness; joint swelling, back pain; joint pain.
Rare (may occur in less than 1 in 1,000 people): feeling of anxiety; tinnitus (ringing in the ears); fainting; increased urine output compared to usual or feeling a stronger urge to urinate; inability to achieve or maintain erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, feeling of "emptiness" in the head; excessive sweating; rash over the entire body; itching; muscle cramps.
If any of these symptoms become severe, you should inform your doctor.

Adverse reactions reported after administration of amlodipine or valsartan alone, which were not observed after administration of Wamlox or which occurred more frequently with amlodipine or valsartan than with Wamlox:

Amlodipine
If any of the following very rare, serious adverse reactions occur after taking the medicine, contact your doctor immediately:

• sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing;
• swelling of eyelids, face or lips;
• swelling of the tongue and throat causing significant breathing difficulties;
• severe skin reactions, including intense rash, urticaria, generalized skin redness, severe itching, blister formation, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• myocardial infarction, cardiac rhythm disturbances;
• pancreatitis, which may cause severe upper abdominal pain radiating to the back, accompanied by very poor general condition.

The following adverse reactions have been reported. If any of these adverse reactions are bothersome to the patient or persist for more than one week, contact your doctor.
Common (may occur in less than 1 in 10 people): dizziness, drowsiness; palpitations (awareness of heartbeat); sudden skin flushing, especially of the face and neck; ankle swelling (edema); abdominal pain, nausea.
Uncommon (may occur in less than 1 in 100 people): mood changes, anxiety, depression, insomnia, tremor, taste disturbances, fainting, lack of pain sensation; visual disturbances, blurred vision, tinnitus; low blood pressure; sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis); dyspepsia, vomiting; hair loss, increased sweating, skin itching, skin color changes; urinary disturbances, increased need to urinate at night, increased frequency of urination; erectile dysfunction, discomfort or enlargement of breasts in men, pain, malaise, muscle pain, muscle cramps; weight gain or weight loss.
Rare (may occur in less than 1 in 1,000 people): disorientation.
Very rare (may occur in less than 1 in 10,000 people): decreased number of white blood cells, decreased number of platelets, which may lead to unusual bruising and easier bleeding; increased blood glucose concentration (hyperglycaemia); gum swelling, abdominal distension (dyspepsia); liver function disorders, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity detected in certain test results; increased muscle tone; vasculitis, often with skin rash, photosensitivity.
Not known (frequency cannot be estimated from available data): tremor, rigidity, mask-like facial expression, slowed movements and shuffling gait, unsteady gait.

Valsartan
Very rare (may occur in less than 1 in 10,000 people): intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
Not known (frequency cannot be estimated from available data): decreased number of red blood cells, fever, sore throat or oral ulcers due to infection; spontaneous bleeding or bruising; high potassium levels in the blood; abnormal liver function test results; kidney function disorders and kidney failure; swelling, mainly of the face and throat; muscle pain; rash, purple-red spots; fever; itching; allergic reactions; blister formation on the skin (a symptom of a disease called bullous pemphigoid).
If any of these symptoms occur, you should immediately inform your doctor.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Wamlox

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must 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

What Wamlox contains

• The active substances are amlodipine (in the form of amlodipine besylate) and valsartan.
  Wamlox 5 mg + 320 mg, film-coated tablets
  Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 320 mg of valsartan.
  Wamlox 10 mg + 320 mg, film-coated tablets
  Each tablet contains 10 mg of amlodipine (as amlodipine besylate) and 320 mg of valsartan.

• Other ingredients are:
  in the tablet core: microcrystalline cellulose (type 200); magnesium stearate, sodium croscarmellose, povidone K25, sodium lauryl sulfate, mannitol and colloidal anhydrous silica,
  in the coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc, iron oxide, yellow (E 172) and iron oxide, red (E 172) – only in 5 mg + 320 mg tablets. See section 2 "Wamlox contains sodium".

What Wamlox looks like and contents of the pack
Wamlox 5 mg + 320 mg, film-coated tablets (tablets)
Brown, biconvex, film-coated, capsule-shaped tablets (tablet dimensions: 16 mm x 8.5 mm, thickness: 5.5 mm – 7.5 mm).
Wamlox 10 mg + 320 mg, film-coated tablets (tablets)
Brownish-yellow, biconvex, film-coated, capsule-shaped tablets, possibly with darker specks (tablet dimensions: 16 mm x 8.5 mm, thickness: 5.8 mm – 7.8 mm).
Wamlox is available in cardboard boxes containing:

• 28 film-coated tablets in blisters.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Krka-farma d.o.o., V. Holjevca 20/E, 10 450 Jastrebarsko, Croatia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany