MOXONIDINE 300 MICROGRAMSTABLETS - patient leaflet, side effects, dosage

1. What Moxonidine is and what it is used for

2.What you need to know before you take Moxonidine

3.How to take Moxonidine

4.Possible side effects

5.How to store Moxonidine

6.Contents of the pack and other information

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What Moxonidine is and what it is used for

• Moxonidine belongs to a group of drugs called anti-hypertensives that lower blood pressure.
• Moxonidine is used to treat high blood pressure.

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What you need to know before you take Moxonidine

Do NOT take Moxonidine if you:

• are allergic (hypersensitive) to moxonidine or any of the other ingredients of this medicine (listed in section 6).
• have a slow heart rate or suffer from an abnormal heart rhythm or a change in the rate of the heart beat called “sick sinus syndrome” or “2nd or 3rd degree AV-block”
• have, or have had, heart failure or other heart problems

Warnings and precautions

Talk to your doctor about taking Moxonidine if you:

• have a heart problem called

“1st degree AV-block”

• have a severe coronary heart disease, or have angina (chest pain at rest)
• have poor circulation
• have kidney disease
• have a rare hereditary problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption as you should not take this medicine.
• are elderly as you may be more susceptible to the effects of blood pressure lowering drugs

Children and adolescents

Do not give this medicine to children and adolescents under 16 years of age because it is unlikely to be safe.

Other medicines and Moxonidine

Talk to your doctor if you are taking any of the following:

• beta-blockers, such as propranolol or atenolol, used to treat heart problems
• other medicines used to reduce blood pressure such as furosemide a diuretic, or captopril an angiotensin-converting enzyme inhibitor
• antidepressants such as amitriptyline sleeping tablets such as zopiclone, tranquilizers such as nitrazepam, lorazepam or phenobarbital
• Moxonidine is removed from body by kidneys through the process called “tubular excretion”. Other medicines removed from the kidneys in the same way could affect how moxonidine works.

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

Moxonidine with food, drink and alcohol

Do not drink alcohol whilst taking Moxonidine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.

Driving and using machines Moxonidine may cause dizziness or drowsiness, if affected do not drive or operate machinery.

Moxonidine contains lactose Patients who are intolerant to lactose should note that Moxonidine tablets contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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^ How to take Moxonidine

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

The tablets should be swallowed, preferably with a drink of water.

The recommended dose is:

Adults (including older people):

Your treatment will normally start with 200 micrograms, taken in the morning. After three weeks, your doctor may increase this dose to 400 micrograms daily, given in a single dose in the morning, or in divided doses in the morning and evening. After another three weeks, your doctor may need to increase this dose to 600 micrograms daily, given in divided doses (morning and evening). You should not take more than 400 micrograms as a single dose, or more than 600 micrograms in any one day.

Patients with kidney problems :

If you have moderate problems with your kidneys, you should not take more than 200 micrograms as a single dose or more than 400 micrograms in total, a day.

If you have severe problems with your kidneys you should not take more than 300 micrograms in total per day.

Use in children and adolescents Moxonidine is not recommended for use in children.

If you take more Moxonidine than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause headache, sleepiness, dry mouth, loss of balance, dizziness, low blood pressure and slowing of the pulse, vomiting, feeling tired, weakness and pain in your stomach. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Moxonidine

If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

If you stop taking Moxonidine Do not suddenly stop taking Moxonidine. Your medicine should be reduced gradually over two weeks, your doctor will advise you on how and when to do this.

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

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Possible side effects

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

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

The following side effects have been reported at the approximate frequencies shown:

Very common ( may affect more than 1 in 10 people):

• dry mouth
• drowsiness

Common (may affect up to 1 in 10 people):

• headache
• dizziness (vertigo)
• flushing (vasodilation).
• weakness or loss of strength
• confusion
• sleep disturbances (difficulty sleeping – insomnia or feeling sleepy – somnolence)
• nausea (feeling sick), being sick (vomiting), stomach upsets (dyspepsia),di­arrhoea
• rash or itching (pruritus)
• back pain

Uncommon (may affect up to 1 in 100 people):

• feeling nervous
• swelling, particularly of the lower legs and feet
• neck pain
• fainting
• unusually slow heart beat (bradycardia)
• low blood pressure, which may result in dizziness or light-headedness on standing
• circulatory disorders, which may produce numbness, coldness or pins-and-needles in the hands or feet
• ringing or noise in the ears (tinnitus)
• leg weakness
• anorexia
• painful neck glands
• dry, itchy or burning sensation in the eyes
• anxiety
• sexual problems such as impotence, or the development of breasts in men, or loss of sexual desire.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: or search for MHRAYellow Card in the Google Play or Apple App Store.

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

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How to store Moxonidine

Keep out of the sight and reach of children.

Do not store above 30°C. Keep blister in the outer carton in order to protect from light. Do not use Moxonidine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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Contents of the pack and other information

What Moxonidine tablets contain:

• The active substance is moxonidine 300 or 400 micrograms.
• The other ingredients are lactose monohydrate, crospovidone, povidone K25 and magnesium stearate. The film coating contains hypromellose, titanium dioxide (E171), macrogol 400 and red iron oxide (E172).

What Moxonidine tablets look like and contents of the pack:

• The 300 microgram tablets are pink, round, film-coated tablets.
• The 400 microgram tablets are dark pink, round, film-coated tablets.
• The product is available in packs of 10, 20, 28, 30, 50, 56, 98, 100 and 400 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG.

Company responsible for manufacture: Merckle GmbH Ludwig-Merckle StraBe 3 89143 Blaubeuren Germany

This leaflet was last revised in March 2021.

PL 00289/0597–8

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