Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Moxonidine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Physiotens contains a medicine called moxonidine. This medicine belongs to a group of medicines called "anti-hypertensives". Physiotens 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.
e Physiotens Do not take Physiotens if:
Do not take Physiotens if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Physiotens. Warnings and precautions Talk to your doctor or pharmacist before taking Physiotens if:
Driving and using machines You may feel sleepy or dizzy while taking Physiotens. If this happens, talk to your doctor before driving or using any tools or machines. Physiotens 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
Physiotens Always take Physiotens exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Taking this medicine
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.
Physiotens Keep out of the sight and reach of children. Do not store above 25°C. Do not use Physiotens after the expiry date which is stated on the carton and blister strips. The expiry date refers to the last day of that month. 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.
What Physiotens contains
Physiotens 400 micrograms Tablets comes as tablet containing 400mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Physiotens 400 micrograms Tablets is moxonidine.
This leaflet reproduces the patient information leaflet approved for Physiotens 400 micrograms Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Mild to moderate essential or primary hypertension.
Adults (including the elderly):
Treatment should be started with 200 micrograms of Physiotens in the morning. The dose may be titrated after three weeks to 400 micrograms, given as one dose or as divided doses (morning and evening) until a satisfactory response has been achieved. If the response is still unsatisfactory after a further three weeks' treatment, the dosage can be increased up to a maximum of 600 micrograms in divided doses (morning and evening).
A single dose of 400 micrograms of Physiotens and a daily dose of 600 micrograms in divided doses (morning and evening) should not be exceeded.
In patients with moderate renal dysfunction (GFR above 30 ml/min, but below 60 ml/min), the single dose should not exceed 200 micrograms and the daily dose should not exceed 400 micrograms of moxonidine.
The tablets should be taken with sufficient liquid. As the intake of food has no influence on the pharmacokinetic properties of moxonidine, the tablets may be taken before, during or after the meal.
Paediatric population
Physiotens is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy.
Physiotens should not be used in cases of:
- hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- sick sinus syndrome or sino-atrial block
- 2nd or 3rd degree atrioventricular block
- bradycardia (below 50 beats/minute at rest)
- severe heart failure (see Section 4.4)
- severe renal dysfunction (GFR <30 ml/min, serum creatinine concentration >160 µmol/l).
Cases of varying degrees of AV block have been reported in the post-marketing setting in patients undergoing moxonidine treatment. Based on these case reports, the causative role of moxonidine in delaying atrioventricular conduction cannot be completely ruled out. Therefore, caution is recommended when treating patients with a possible predisposition to developing an AV block. When moxonidine is used in patients with 1st degree AV block, special care should be exercised to avoid bradycardia. Moxonidine must not be used in higher degree AV blocks (see section 4.3)
When moxonidine is used in patients with severe coronary artery disease or unstable angina pectoris, special care should be exercised due to the fact that there is limited experience in this patient population.
Caution is advised in the administration of moxonidine to patients with renal impairment as moxonidine is excreted primarily via the kidneys. In these patients careful titration of the dose is recommended, especially at the start of therapy. Dosing should be initiated with 200 micrograms daily and can be increased to a maximum of 400 micrograms daily for patients with moderate renal impairment (GFR above 30 ml/min, but below 60 ml/min), if clinically indicated and well tolerated.
If Moxonidine is used in combination with a beta-blocker and both treatments have to be discontinued, the beta-blocker should be discontinued first and then Moxonidine after a few days.
So far, no rebound-effect has been observed on the blood pressure after discontinuing the treatment with moxonidine. However, an abrupt discontinuance of the moxonidine treatment is not advisable; instead the dose should be reduced gradually over a period of two weeks.
Due to a lack of clinical data supporting the safety in patients with co-existing moderate heart failure, Physiotens must be used with caution in such patients.
The elderly population may be more susceptible to the cardiovascular effects of blood pressure lowering drugs. Therefore therapy should be started with the lowest dose and dose increments should be introduced with caution to prevent the serious consequences these reactions may lead to.
Patients with rare hereditary problems of galactose intolerance, the rare Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Due to a lack of data on safety and efficacy, Physiotens should not be used in children and adolescents below 18 years of age.
Concurrent administration of other antihypertensive agents enhances the hypotensive effect of Physiotens
Since tricyclic antidepressants may reduce the effectiveness of centrally acting antihypertensive agents, it is not recommended that tricyclic antidepressants be co- administered with moxonidine.
Moxonidine can potentiate the sedative effect of tricyclic anti-depressants (avoid co-prescribing), tranquillisers, alcohol, sedatives and hypnotics.
Moxonidine moderately augmented the impaired performance in cognitive functions in subjects receiving lorazepam. Moxonidine may enhance the sedative effect of benzodiazepines when administered concomitantly.
Moxonidine is excreted through tubular excretion. Interaction with other agents that are excreted through tubular excretion cannot be excluded.
Pregnancy:
There are no adequate data from use of moxonidine in pregnant woman. Studies in animals have shown embryo-toxicological effects (see section 5.3). The potential risk for humans is unknown. Moxonidine should not be used during pregnancy unless clearly necessary.
Breast-feeding:
Moxonidine is secreted in breast milk and should therefore not be used during breast -feeding.
If therapy with moxonidine is considered absolutely necessary, breast-feeding should be stopped.
No studies on the effects on the ability to drive and use machines have been performed.
Somnolence and dizziness have been reported. This should be borne in mind when performing these tasks.
Most frequent side effects reported by those taking moxonidine include dry mouth, dizziness, asthenia and somnolence. These symptoms often decrease after the first few weeks of treatment.
Undesirable Effects by System Organ Class (observed during placebo-controlled clinical trials with n=886 patients exposed to moxonidine resulted in frequencies below):
MedDRA system organ class
Very Common
≥1/10
Common
≥1/100, <1/10
Uncommon
≥1/1,000, <1/100
Cardiac disorders
Bradycardia
Ear and labyrinth disorders
Tinnitus
Nervous system disorders
Headache*,
Dizziness/Vertigo, Somnolence
Syncope*
Vascular disorders
Hypotension*
(including orthostatic)
Gastrointestinal disorders
Dry mouth
Diarrhoea,
Nausea/Vomiting/ Dyspepsia
Skin and subcutaneous tissue disorders
Rash/ Pruritus
Angioedema
General disorders and administration site reactions
Asthenia
Oedema
Musculoskeletal and connective tissue disorders
Back pain
Neck pain
Psychiatric disorders
Insomnia
Nervousness
* there was no increase in frequency compared to placebo
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Symptoms of overdose
In the few cases of overdose that have been reported, a dose of 19.6 mg was ingested acutely without fatality. Signs and symptoms reported included: headache, sedation, somnolence, hypotension, dizziness, asthenia, bradycardia, dry mouth, vomiting, fatigue and upper abdominal pain. In case of a severe overdose close monitoring of especially consciousness disturbances and respiratory depression is recommended.
In addition, based on a few high dose studies in animals, transient hypertension, tachycardia, and hyperglycaemia may also occur.
Treatment of overdose
No specific antidote is known. In case of hypotension, circulatory support such as fluids and dopamine administration may be considered. Bradycardia may be treated with atropine. α-Receptor antagonists may diminish or abolish the paradoxal hypertensive effects of a moxonidine overdose.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Physiotens 400 micrograms Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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