nnogen Pharma

FOR THE USER

Methyldopa 125mg, 250mg and 500mg tablets

(methyldopa)

Read all of tills 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 doctororpharmacist.

•    This medicine has been prescribed for you. Do not pass il 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 Methyldopa 125mg, 250mg and 500mg tablets are and what they are used for

2.    Before you take Methyldopa 125mg, 250mg and 500mg tablets

3.    How to take Methyldopa 125mg, 250mg and 500mg tablets

4.    Possible aide effects

5.    How to store Methyldopa 125mg, 250mg and 5Q0mg tablets

6.    Further Information

Methyldopa 125mg, 250mg and 500mg tablets contain the active ingredient methyldopa. Methyldopa belongs to a group of medicines called 'anti-hypertensive' agents.

These tablets are used to treat high blood pressure (hypertension).

Do not take Methyldopa 125mg, 250mg and 500mg tablets If:

•    You are sensitive to or have previously experienced sensitivity to methyldopa or any of the other ingredients in this medicine

•    You have liver problems including hepatitis and Cirrhosis

•    You have phaeochromocytoma (a rare tumour of the adrenal gland which causes high blood pressure)

•    You suffer from depression

•    You aro taking monoamine oxidase inhibitors (MAOI)- 8 type of antidepressant

Take special care with Methyldopa 125mg, 250mg and 500mg tablets:

Check with your doctor or pharmacist before using your medicine if:

•    You have kidney problems

•    You suffer from a condition known as porphyria

•    You are taking other medicines to lower your blood pressure

•    You have damaged or diseased blood vessels In your brain

•    You have a history of liver disease and/or liver problems

Check with your doctor while taking this medicine if you are going to have:

•    Dialysis

•    An operation

•    A blood transfusion.

Tests you may have while taking Methyldopa tablets

Your doctor may do blood tests to check how your liver is working during the first 6-12 weeks. He or she may use similar tests if you have a fever at any time while you are taking this medicine.

Tell your doctor you are taking this medicine If you have a laboratory test where a urine or blood sample Is taken. This Is because methyldopa may affect the results of some types of tests.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Methyldopa tablets.

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 as some drugs may affect each other's action. This Includes herbal medicines.

Do not take Methyldopa tablets if you are taking a type of medicine called a 'monoamine oxidase Inhibitor* (MAOI) used to treat depression.

It Is particularly Important that you tell your doctor or pharmacist if you are taking any of the following before taking Methyldopa tablets:

•    Other medicines for high blood pressure in particular reserpine, also used to treat mental illness, hydralazine and mebutamate also used as a sedative

•    Lithium - used to treat some types of depression

•    Medicines called 'phenothlazines' such as chlorpromazlne - used for mental illness and sometimes feeling and being sick

•    Medicines called Tricyclic antidepressants' -used to treat depression

•    Cough and cold remedies that contain a decongestant

•    Iron and supplements containing iron, such as multivitamins with minerals

Pregnancy and breast-feeding You should check with your doctor before taking Methyldopa tablets If you are or think you may be pregnant, if you are planning to become pregnant or If you are breast-feeding,

Driving and using machines Methyldopa can make you feel sleepy. You should not drive, operate machinery or carry out other activities requiring full alertness whilst taking this medicine If you experience this effect.

Important Information about some of the Ingredients in this medicine Methyldopa 125mg and 250mg tablets contain lactose. If you have been told by your doctor that you have an Intolerance to some sugars, you should talk to your doctor before taking this medicine.

Methyldopa 125mg, 250mg and 500mg tablets contain tartrazine (E102) which may cause an allergic reaction._

Always take Methyldopa 125mg, 250mg and 500mg tablets exactly as your doctor has Instructed you. You should check with your doctor or pharmacist If you are unsure.

The tablets should be swallowed with water. Adults:

Usual dosage:

Starting dose is 250mg twice a day for 2 days.

This dose may be Increased by your doctor by 250-500mg daily, at Intervals of at least 2 days.

This Increase may continue until satisfactory control of your blood pressure Is achieved.

Once control has been achieved, the daily dose will be In the region of 500mg-2000mg.

Elderly:

The starting dose may be lov/er.

Your doctor will tell you exactly the dose to take and how often to take it.

Patients with kidney problems:

If you have problems with your kidneys, your starting dose may be lower than the adult dose above.

Your doctor will tell you exactly the dose to take and how often to take it.

If you are already taking other medicines for high blood pressure (diuretics):

Your starting dose may be lower.

Your doctor will tell you exactly the dose to take and how often to take it.

The medicine you are currently taking will be gradually withdrawn and the dose of Methyldopa tablets will be gradually Increased.

This Increase In dose of Methyldopa tablets will be adjusted upwards by 250mg to 500mg at 2 to 7 day intervals to maintain control of your blood pressure.

If you take more Methyldopa 125mg, 250mg and 500mg tablets than you should If you take an unintentional extra dose, this should not be a problem. If you (or someone else) swallow a lot of tablets altogether, or if you think a child has swallowed one of the tablets, contact your nearest accident and emergency department or doctor immediately.

Symptoms of overdose Include excessive drowsiness, weakness, slow heart rate, low blood pressure, dizziness, light-headedness, painful Infrequent bowel movements, feeling bloated, wind, diarrhoea, feeling or being sick.

If you forget to take Methyldopa 125mg, 250mg and 500mg tablets

If you forget to take a dose, take the missed dose as soon as you remember. If your next dose is due within 4 hours, skip the missed dose and take your next dose at the usual time.

If you stop taking Methyldopa 125mg, 250mg and SOOmg tablets

Do not stop taking these tablets without talking to your doctor. The dose needs to be gradually reduced. If you stop taking these tablets you will experience a rise in blood pressure and your original symptoms will return.

Like all medicines, Methyldopa Tablets can cause side effects, although not everybody gets them. You may feel dizzy or lightheaded when standing up quickly or after exercising which Is associated with lowering of blood pressure although this is less common than with some other antihypertensive medicines.

Contact your doctor IMMEDIATELY if you have any of the following side effects as they are serious and require medical attention:

•    An allergic reaction symptoms such as shortness of breath, skin rash or itching, hives, swelling of your lips, face or tongue, chills or fever or painful joints.

•    Chest pain, slow heart rate, or existing angina made worse

•    Severe skin reactions (such as painful reddening, followed by blistering and peeling of layers of skin)

•    Liver problems, including jaundice and hepatitis - signs Include yellowing of your skin and eyes, sometimes with a fever, pale stools and dark urine

. Pain in the gut and diarrhoea caused by inflammation of Die bowel (colitis)

•    Severe pain In the gut 8nd back caused by inflammation of the pancreas (pancreatitis).

Other unwanted effects which may occur while taking Methyldopa Tablets are:

Blood:

•    Reduction in red blood cells (anaemia) tills can make your skin pale and make you weak or breathless

•    Abnormal blood lest causing symptoms such as pale skin, tiredness, fever and sore throat

•    Bruising and prolonged bleeding after Injury

Your medicine may alter the numbers and types of your blood cells and cause a rise In urea In the blood.

Nervous system:

•    Feeling sleepy or tired - this may happen at the start of treatment or when the dose Is Increased, and usually goes away

•    Headache or feeling weak this may happen at the start of treatment and usually goes away

•    Pins and needles

•    Being unable to move part of your face (paralysis)

•    Having movements you cannot control

. Parkinsonism with symptoms such as tremor, a decrease in body movements with an Inability to move your muscles

•    Confusion

•    Frequent dizziness or fainting

•    Dizziness due to low blood pressure and lightheadedness (particularly when standing up quickly)

Nose and chest:

•    Nasal stuffiness

Stomach and gut:

•    Feeling sick (nausea)

•    Being sick (vomiting)

•    Abdominal pain

•    Feeling bloated

•    Constipation

•    Excess wind

•    Diarrhoea

•    Dry mouth

•    Sore or black tongue

Skin and hair:

•    Skin rash or peeling skin

Joints and muscles:

•    Painful and/or swollen Joints

•    Muscle pains

Infections:

•    Swelling of salivary glands

General:

•    Water retention causing swelling and weight gain

•    Fever

Allergic:

• Inflammation of heart muscle or the sac surrounding the heart, skin rash which may be red and/or scaly, fever.

Sexual:

•    Breast enlargement

•    Breast development in men

•    Loss of periods in women

•    Abnormal production of milk

•    Changes in sexual function such as Impotence and not being able to ejaculate

•    Decreased sex drive

Psychiatric:

•    Mental changes, Including nightmares or depression

•    Delusions and paranoia - which will stop when you stop taking this medicine

Laboratory tests:

Your doctor may need to carry out simple blood

tests during tire first few months of therapy with

Methyldopa tablets. Results could show:

•    A decrease in blood cell production

•    An Increase in some white blood cells

•    Abnormal levels of prolactin

•    A positive result for antinuclear antibodies, LE cells and rheumatoid factor

You may also notice that your urine may appear darker after urination.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE METHYLDOPA 125MG, 250MG AND SDOMG TABLETS

Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.

Methyldopa 125mg tablets: Store in a cool, dry place and protect from light.

Methyldopa 250mg and 500mg tablets: Store below 25 C. Protect from light.

In case of any visible signs of deterioration, you should discard the package.

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

Keep out of the reach and sight of children

What Methyldopa 125mg, 250mg and 500mg tablets contain:

Methyldopa 125mg tablets contain 125mg of

methyldopa In each tablet

Methyldopa 250mg tablets contain 250mg of

methyldopa in each tablet

Methyldopa 500mg tablets contain 500mg of

methyldopa In each tablet

The other ingredients are: sodium calcium edetate, citric acid, ethyl cellulose, furcellaran, microcrystalline cellulose, magnesium stearate, hyprometlose, povidone, castor oil, tartrazine (E102). The 125mg and 250mg tablets also contain lactose. The 125mg and 500mg tablets also contain talc and In addition the 50umg contain colloidal silicon dioxide.

What Methyldopa 125mg, 250mg and 500mg tablets look like and contents of the pack Methyldopa Tablets 125mg, 250mg and 500mg tablets are yellow, round slightly biconvex tablets with a dividing groove.

Methyldopa 125mg, 250mg and 500mg tablets are available in packs of 28, 30, 56, 60, 84, 90,100, 112 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

This leaflet was last amended In January 2015