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HYPOLAR RETARD 20

Active substance(s): NIFEDIPINE / NIFEDIPINE

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Sandoz Ltd
Hypolar Retard 10mg and 20mg

PL 04416/0283 & 0245

28/02/2017

Package leaflet: Information for the user
HYPOLAR® RETARD 10 mg MR Tablets
HYPOLAR® RETARD 20
(Nifedipine)
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
DO NOT take Hypolar Retard Tablets if:
• 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
PIL.0283-0245.002d

V06: CDS update

SL

Sandoz Ltd
Hypolar Retard 10mg and 20mg

PL 04416/0283 & 0245

28/02/2017

• 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.
PIL.0283-0245.002d

V06: CDS update

SL

Sandoz Ltd
Hypolar Retard 10mg and 20mg

PL 04416/0283 & 0245

28/02/2017

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.

PIL.0283-0245.002d

V06: CDS update

SL

Sandoz Ltd
Hypolar Retard 10mg and 20mg

PL 04416/0283 & 0245

28/02/2017

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,
PIL.0283-0245.002d

V06: CDS update

SL

Sandoz Ltd
Hypolar Retard 10mg and 20mg

PL 04416/0283 & 0245

28/02/2017

• 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
What Hypolar Retard Tablets Contain
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.
PIL.0283-0245.002d

V06: CDS update

SL

Sandoz Ltd
Hypolar Retard 10mg and 20mg

PL 04416/0283 & 0245

28/02/2017

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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