HYPOLAR RETARD 20 - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet.You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.

In this leaflet:

• 1. What Hypolar Retard Tablets are and what they are used for

• 2. Before you take Hypolar Retard Tablets

• 3. How to take Hypolar Retard Tablets

• 4. Possible side effects

• 5. How to store Hypolar Retard Tablets

• 6. Further information

1. What Hypolar Retard Tablets are and what they are used for

Hypolar Retard Tablets contain the active substance Nifedipine. This belongs to a group of medicines known as calcium antagonists. These work by opening up the blood vessels and increasing the flow of blood through them.

Hypolar Retard Tablets are used:

• For the prevention of certain types of angina pectoris. Angina is chest pain caused by a narrowing of the arteries in the heart muscle.
• For the treatment of mild to moderate high blood pressure (hypertension).

2. Before you take Hypolar Retard Tablets

You know that you are allergic to Nifedipine or any of the other ingredients (listed at the end of this leaflet)

• You have a severe problem with your heart which causes collapse and a sudden fall in your blood pressure
• You have a severe constriction of the main blood vessel from the heart called aortic stenosis
• You have heart failure
• You have had a heart attack in the last month
• You are suffering from shock induced by heart circulatory collapse
• You suffer with unstable angina
• You suffer from porphyria, a rare inherited metabolic disorder affecting the blood.

Hypolar Retard Tablets should not be given to children.

Take special care with Hypolar Retard Tablets and check with your doctor or pharmacist before taking your medicine if you:

• have any liver or kidney problems.
• have heart problems which cause you to get breathless even with the slightest exercise.
• suffer from low blood pressure causing dizziness or fainting on standing up.
• are diabetic.
• have drunk grapefruit juice within the last three days.

These tablets may alter the results of some urine tests. If you have given a urine sample, inform the person responsible that you are taking this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or having recently taken any other medicines, including medicines obtained without a prescription.

The effects of any of these medicines may change, particularly if you are taking:

• other medication for angina and/or high blood pressure.
• any other drug for the treatment of heart problems (especially digoxin, quinidine, diltiazem or betablockers).
• any drugs containing cimetidine (for the reduction of stomach acidity and treatment of ulcers).
• any drugs to treat asthma such as theophylline.
• any drugs to control seizure (fits) or epilepsy such as phenytoin, carbamazepine, primidone.
• any antibiotics such as rifampicin or combination treatment quinupristin/dal­fospristin.
• cisapride, a drug used to treat reduced movements of the gullet and stomach.
• vincristine, used to treat cancers.

The effect of the following drugs on Hypolar Retard is uncertain. Therefore, as an additional precaution, please tell your doctor if you are taking:

• the antibiotic erythromycin, or the anti-fungals, ketoconazole, itraconazole or fluconazole.
• the HIV drugs indinavir, nelfinavir, ritonavir, saquinavir or amprenavir.
• the antidepressant drugs fluoxetine and nefazodone.
• tacrolimus, an immunosuppressant used to prevent the rejection of transplant organs.
• carbamazepine and valproic acid, which are both used for the treatment of epilepsy.
• the barbiturate phenbarbital, used primarily to treat insomnia and anxiety.

The following medicines, when taken with Hypolar Retard Tablet, may cause an increase of blood pressure:

• corticosteroids (anti-inflammatory drugs).
• oestrogen (the female hormone used as a contraceptive).
• alprostadil and vadenafil, used in the treatment of erectile dysfunction (problem maintaining an erection in men).

If you are going to have an operation, you should make sure the doctor or anesthetist know you are taking nifedipine as it can increase the effect of the muscle relaxant drugs such as tubocurarine, often used in surgery.

Taking Hypolar Retard Tablets with food and drink

The tablets should be swallowed whole with a glass of water either during or after eating. Do not bite or chew the tablet.

Do not take Hypolar Tablets with grapefruit juice.

Avoid alcohol whilst taking Hypolar Retard Tablets, it can increase the effect of this medicine.

Pregnancy and breast-feeding

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

Hypolar Retard Tablets should not be taken if you are pregnant, think you are pregnant or are planning to become pregnant, or if you are breast feeding.

Driving and using machines

Do not drive, operate machinery or carry out other activities requiring full alertness if you suffer with headaches, dizziness, tiredness or nausea (feeling sick) while taking this medicine.

Important information about some of the ingredients of Hypolar Retard Tablets

This medicine contains lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

3. how to take hypolar retard tablets

Always take Hypolar Retard Tablets exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

• Two Hypolar 10 mg MR Tablets (20 mg), twice daily or one Hypolar Retard 20 Tablets (20 mg), twice daily.

This may be adjusted up or down depending on your condition.

If you take more Hypolar Retard Tablets than you should:

Taking too many Hypolar Retard tablets can cause a severe drop in blood pressure, a slow heart rate and unconsciousness. If you take more tablets than you should contact your doctor or hospital immediately. Take any remaining tablets or this leaflet with you so the medical staff know exactly what you have taken.

If you forget to take your Hypolar Retard Tablets:

If you forget to take a tablet, take it if you remember within 12 hours of your usual time. If more than 12 hours have passed, you should not take the missed tablet but should take your next tablet at the normal time when it is due.

If you stop taking Hypolar Retard Tablets

Do not stop taking your tablets suddenly as your condition may get worse. Consult your doctor first.

If you have any further questions about these tablets, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Hypolar Retard Tablets can cause side effects, although not everybody gets them.

Stop taking Hypolar Retard Tablets and tell your doctor immediately if you experience:

• signs of an allergic reaction such as skin rash, itching, swollen lips, difficulties in breathing.
• chest pain occurring within 1 to 4 hours of taking the first dose of these tablets.

Other side effects may include:

Common side effects (probably occurring in less than 1 in 10 people) are

• headache,
• dizziness,
• feeling sick,
• reduced blood pressure (you may feel faint),
• numbness and tingling sensations in fingers,
• redness of skin (flushing),
• swelling of the hands and feet,
• an increase in, or awareness of heartbeat.

Uncommon side effects (probably occurring in less than 1in 100 people) are:

• rash,
• lethargy (general weakness and loss of strength and energy),
• increased or painful urination (passing of water),
• tremors or shaking of the limbs,
• fainting,
• chills,
• blocked or stuffy nose,
• nosebleeds,
• excessive sweating,
• anxiety,
• problems sleeping,
• spinning sensation,
• migraine,
• stomach upsets (stomach pains, diarrhoea, indigestion),
• feeling of pins and needles,
• muscle pains,
• visual disturbances.

Rare cases (probably occurring in less than 1 in 1000 people) are:

• jaundice (yellowing of the skin and eyes from liver damage),
• loss of appetite,
• changes in mood,
• high blood sugar levels,
• difficulties with erections in men (impotence),
• purple spots on the skin,
• sensitivity to light ,
• changes to the blood, symptoms of this include fever, joint pain, stiffness, sore throat and general feeling of being unwell.

Frequency not known:

• Shortness of breath

Swelling of the gums and enlargement of breasts in older men who have been taking nifedipine for a long time have occurred. These are reversible when nifedipine is withdrawn.

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 hypolar retard tablets

Keep out of the reach and sight of children.

Do not use Hypolar Retard Tablets after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

Do not store above 25°C.

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

Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give this medicine to someone else, it could harm them, even if their symptoms seem the same as yours.

6. Further information

There are two strengths of Hypolar Retard tablets.

Hypolar retard 10mg MR Tablets contain 10 mg of the active substance is nifedipine.

Hypolar retard 20mg contain 20 mg of the active substance is nifedipine.

The other ingredients are microcrystalline cellulose, lactose, maize starch, talc, hypromellose, magnesium stearate, polysorbate, macrogol 4000 and the colours: iron oxide (E172) and titanium dioxide (E171).

What Hypolar Retard Tablets look like and contents of the pack

Hypolar Retard 10mg MR Tablets are round biconvex coated tablets, pale red in colour.

Hypolar Retard 10mg MR Tablets come in packs of 56.

Hypolar Retard 20 are round biconvex coated tablets,

pale red in colour and embossed with “NIF 20”.

Hypolar Retard 20 come in blister packs of 56.

Marketing Authorisation Holder and Manufacturer Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK

This leaflet was last revised 02/2017

PIL.0283–0245.002d

V06: CDS update

SL