1. What Lotense is and what it is used for

Lotense contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists. Lotense is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina. In patients with high blood pressure your medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Lotense works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Your medicine does not provide immediate relief of chest pain from angina.

2. Before you take Lotense

Do not take Lotense

- If you are allergic (hypersensitive) to amlodipine, or any of the other ingredients of your medicine, or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing.

- If you have severe low blood pressure (hypotension).

- If you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).

- If you suffer from heart failure after a heart attack.

Take special care with Lotense

You should inform your doctor if you have or have had any of the following conditions:

- Recent heart attack.

- Heart failure.

- Severe increase in blood pressure (hypertensive crisis).

- Liver disease. You are elderly and your dose needs to be increased.

Use in children and adolescents

Lotense has not been studied in children under the age of 6 years. Lotense should only be used for hypertension in children and adolescents from 6 years to 17 years of age.

For more information, talk to your doctor.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Lotense may affect or be affected by other medicines, such as:

- Ketoconazole, itraconazole (anti-fungal medicines).

- Ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV).

- Rifampicin, erythromycin, clarithromycin (antibiotics).

- Hypericum perforatum (St. John’s Wort).

- Verapamil, diltiazem (heart medicines).

- Dantrolene (infusion for severe body temperature abnormalities).

- Simvastatin (a cholesterol lowering medicine).

Lotense may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.

Taking Lotense with food and drink

Grapefruit juice and grapefruit should not be consumed by people who are taking Lotense. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Lotense.

Pregnancy

The safety of amlodipine in human pregnancy has not been established. If you think you might be pregnant, or are planning to get pregnant, you must tell your doctor before you take Lotense.

Breast-feeding

It is not known whether amlodipine is passed into breast milk. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Lotense.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Lotense may affect your ability to drive or use machines. If the capsules make you feel sick, dizzy or tired, or give you a headache, do not drive or use machines and contact your doctor immediately.

3. How to take Lotense

Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual initial dose is Lotense 5 mg once daily. The dose can be increased to Lotense 10 mg once daily. Your medicine can be used before or after food and drinks. You should take your medicine at the same time each day with a drink of water. Do not take Lotense with grapefruit juice.

Use in children and adolescents

For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day. It is important to keep taking the capsules. Do not wait until your capsules are finished before seeing your doctor.

If you take more Lotense than you should

Taking too many capsules may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Seek immediate medical attention if you take too many Lotense capsules.

Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24-48 hours after intake.

If you forget to take Lotense

Do not worry. If you forget to take a dose, leave out that dose completely. Take your next dose at the right time. Do not take a double dose to make up for a missed dose.

If you stop taking Lotense

Your doctor will advise you how long to take your medicine. Your condition may return if you stop using your medicine before you are advised.

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

4. Possible side effects

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

Visit your doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine.

- Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing.

- Swelling of eyelids, face or lips.

- Swelling of the tongue and throat which causes great difficulty breathing.

- Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions.

- Heart attack, abnormal heart beat.

- Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell.

The following common side effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor.

Common: Affects 1 to 10 users in 100

- Headache, dizziness, sleepiness (especially at the beginning of treatment).

- Palpitations (awareness of your heart beat), flushing.

- Abdominal pain, feeling sick (nausea).

- Ankle swelling (oedema), tiredness.

Other side effects that have been reported include the following list. If any of these get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Uncommon: Affects 1 to 10 users in 1,000

- Mood changes, anxiety, depression, sleeplessness.

- Trembling, taste abnormalities, fainting, weakness.

- Numbness or tingling sensation in your limbs; loss of pain sensation.

- Visual disturbances, double vision, ringing in the ears. Low blood pressure. Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis).

- Altered bowel habits, diarrhea, constipation, indigestion, dry mouth, vomiting (being sick).

- Hair loss, increased sweating, itchy skin, red patches on skin, skin discoloration.

- Disorder in passing urine, increased need to urinate at night, increased number of times of passing urine.

- Inability to obtain an erection, discomfort or enlargement of the breasts in men.

- Weakness, pain, feeling unwell.

- Joint or muscle pain, muscle cramps, back pain.

- Weight increase or decrease.

Rare: Affects 1 to 10 users in 10,000

- Confusion

Very rare: Affects less than 1 user in 10,000

- Decreased numbers of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding (red blood cell damage).

- Excess sugar in blood (hyperglycaemia).

- A disorder of the nerves which can cause weakness, tingling or numbness.

- Cough, swelling of the gums.

- Abdominal bloating (gastritis).

- Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests.

- Increased muscle tension.

- Inflammation of blood vessels, often with skin rash.

- Sensitivity to light.

- Disorders combining rigidity, tremor, and/or movement disorders.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Lotense

Keep out of reach of children.

Store below 30°C.

Do not use beyond the expiry date or if the product shows any visible sign of deterioration.