Patient leaflet - Moxonidine 200 micrograms tablets
What Moxonidine is and what it is used for
Moxonidine contains a medicine called moxonidine. This medicine belongs to a group of medicines called “anti-hypertensives”.
Moxonidine is used to treat high blood pressure (hypertension). It works by making your blood vessels relax and widen. This helps to lower your blood pressure.
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 Moxonidine (listed in Section 6)
* you have a slow heart rate caused by a heart problem called “sick sinus syndrome” or “2nd or 3rd degree AV-block”
* you have heart failure.
* you have serious kidney problems
Do not take Moxonidine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Moxonidine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Moxonidine if: * you have a heart problem called “1st degree AVblock”
* you have a severe heart problem such as angina or chest pain at rest * you have kidney problems. Your doctor may need to adjust your dose. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Moxonidine.
Other medicines and Moxonidine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Moxonidine can affect the way some other medicines work. Also some other medicines can affect the way Moxonidine works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
* other medicines to lower your blood pressure.
Moxonidine may increase the effect of these medicines
* medicines for depression such as imipramine or amitriptyline * tranquillisers, sedatives or sleeping tablets such as benzodiazepines * beta-blockers (see “If you stop taking Moxonidine” in Section 3) * Moxonidine is removed from your body by your kidneys through a process called “tubular excretion”. Other medicines removed from the kidneys in the same way could affect how Moxonidine works.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Moxonidine.
Moxonidine with food, drink and alcohol
* You can take the tablets with or without food.
* Do not drink alcohol while you are taking
Moxonidine. This is because Moxonidine may increase the effects of alcohol.
Pregnancy and breast-feeding
* Tell your doctor if you are pregnant or might become pregnant. Your doctor will normally advise you to stop taking Moxonidine. Your doctor will advise you to take another medicine instead of Moxonidine.
* Tell your doctor if you are breast-feeding or about to start breast-feeding. Moxonidine is not recommended for mothers who are breastfeeding. Your doctor may advise you to take another medicine if you want to breast-feed, or may ask you to stop breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
You may feel sleepy or dizzy while taking Moxonidine. If this happens, talk to your doctor before driving or using any tools or machines.
Moxonidine contains 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
How to take Moxonidine
Always take Moxonidine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
* Swallow the tablets whole with a glass of water.
* Try to take your tablets around the same time each day. This will help you remember to take them.
How much to take
The usual starting dose is 200 micrograms a day.
* Your doctor may increase this dose to up to 600 micrograms a day. You should not take more than 400 micrograms as a single dose or more than 600 micrograms in any one day.
* If your doctor has told you to take 600 micrograms a day, this should be split in two (300 micrograms in the morning and 300 micrograms in the evening).
* Your doctor may tell you to take a lower dose if you have kidney problems.
Use in children and adolescents
Moxonidine should not be given to children and adolescents under 18 years.
Ref: 2495/030723/1/F
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Patient Information Leaflet (continued)
If you take more Moxonidine than you should
If you take more Moxonidine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen: headache, feeling sleepy (somnolence, sedation), fall in blood pressure (hypotension), slow heart rate (bradycardia), feeling dizzy (vertigo), dry mouth, being sick (vomiting), feeling tired (fatigue), weakness and pain in your stomach (abdominal pain).
If you forget to take Moxonidine
* If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. * Do not take a double dose to make up for a forgotten dose.
If you stop taking Moxonidine
* Keep taking your tablets until your doctor decides that you should stop. * If you need to stop, your doctor will lower your dose slowly over a few weeks. If you are taking more than one medicine for high blood pressure (such as beta-blockers), your doctor will tell you which medicine to stop first. This is so that your body can adjust slowly to the change.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Moxonidine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Stop taking Moxonidine and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
* swelling of the face, lips or mouth (angioedema). This is uncommon, affecting less than 1 in 100 people.
Other side effects include:
Very Common (affects more than 1 in 10 people)
* dry mouth.
Common (affects less than 1 in 10 people)
* back pain
* headache
* weakness (asthenia)
* feeling dizzy (vertigo)
* rash or itching (pruritus)
* difficulty sleeping (insomnia), feeling sleepy (somnolence) * feeling sick (nausea), diarrhoea, being sick (vomiting), indigestion (dyspepsia).
Uncommon (affects less than 1 in 100 people)
* neck pain
* feeling nervous
* fainting (syncope)
* swelling (oedema)
* ringing or noise in the ears (tinnitus)
* unusually slow heartbeat (bradycardia)
* low blood pressure, including low blood pressure when standing up.
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 Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow 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.
How to store Moxonidine
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not take this medicine after the expiry date which is stated on the blister label and carton after EXP. The expiry date refers to the last day of the month. If your doctor tells you to stop taking this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor advises you to.
If your medicine becomes discoloured or shows any other signs of deterioration, ask your pharmacist who will advise you on what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
What Moxonidine contains
Each tablet contains 200 micrograms of moxonidine, the active substance. The other ingredients are lactose monohydrate, povidone, crospovidone, magnesium stearate, hypromellose, ethylcellulose, macrogol 6000, talc, red iron oxide (E172), titanium dioxide (E171).
What Moxonidine looks like and contents of the pack Moxonidine are pale pink, round, biconvex, film-coated tablets imprinted ‘0.2’ on one face and plain on the other.
Moxonidine tablets come in a pack of 28 tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Mylan Laboratories SAS, Route de Belleville, Lieu-dit ‘Maillard’, 01400 Châtillon-sur-Chalaronne, France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
PL 15184/2495 Moxonidine 200 micrograms Tablets
Leaflet revision date: 03/07/23
Blind or partially sighted? Is this leaflet hard to see or read? Phone Lexon (UK) Limited, Tel: 01527 505414 to obtain the leaflet in a format suitable for you
Ref: 2495/030723/1/B
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Moxonidine 200 micrograms Tablets
POM