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Amitriptyline Remedica 10 mg and 25 mg film-coated tablets – amitriptyline for depression, neuropathic pain and headache prevention
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- Stock: Zabrana online prodaje
- Brand: OSTALO
- Model: BR-60516513521021202
Amitriptyline Remedica is a medicine containing the active substance amitriptyline (as amitriptyline hydrochloride) and belongs to the group of tricyclic antidepressants. In Serbia it is authorised as film-coated tablets of 10 mg and 25 mg and is available on prescription only.
In addition to treating depression in adults, according to the approved leaflet amitriptyline is also used for neuropathic pain, for the prevention of chronic tension-type headache and migraine and – only in special cases and under a specialist – for night-time bedwetting in children aged 6 years and older. The dose is always set by the doctor, and treatment is started and stopped gradually.
Important warning
- Supply status in Serbia: prescription-only medicine.
- At the start of antidepressant treatment, thoughts of self-harm or suicide may appear or worsen, especially in people under 25 – in that case contact your doctor or emergency services immediately.
- The medicine must not be taken with MAO inhibitors (or within 14 days of them), after a recent heart attack, with heart block or heart rhythm disorders, or with severe liver disease.
- The medicine may cause drowsiness and dizziness, especially at the start of treatment; alcohol increases the sedative effect.
- Do not stop the medicine suddenly without agreeing this with your doctor.
- This page is for information only and is not an offer to buy the medicine online.
What is Amitriptyline Remedica (amitriptyline) used for and how should it be taken?
Key facts about the medicine
| Name of the medicine | Amitriptyline Remedica, 10 mg and 25 mg, film-coated tablets |
|---|---|
| Active substance | amitriptyline (as amitriptyline hydrochloride) |
| Strength | 10 mg or 25 mg amitriptyline hydrochloride per film-coated tablet |
| Pharmaceutical form | film-coated tablet for oral use |
| Therapeutic group | psychoanaleptics – tricyclic antidepressants, non-selective monoamine reuptake inhibitors (ATC N06AA09) |
| Pack | 10 mg: 100 film-coated tablets (10 blisters of 10); 25 mg: 30 film-coated tablets (3 blisters of 10) |
| Marketing authorisation holder / manufacturer | FARMALOGIST D.O.O. BEOGRAD / REMEDICA LTD, Limassol, Cyprus |
| Supply status | prescription-only medicine (R) |
What is Amitriptyline Remedica used for?
According to the approved leaflet, Amitriptyline Remedica is used for:
- the treatment of major depressive episodes in adults;
- the treatment of neuropathic pain in adults (chronic pain caused by damage or disease of the nervous system);
- the prevention (prophylaxis) of chronic tension-type headache in adults;
- the prevention of migraine in adults;
- the treatment of night-time bedwetting in children aged 6 years and older, only when organic causes (e.g. spina bifida) have been excluded and other treatments, including antispasmodics and desmopressin, have not worked; this treatment is prescribed only by a doctor experienced in treating bedwetting.
For depression, neuropathic pain and headache the medicine is not intended for children and adolescents under 18 years, because safety and efficacy in this age group have not been established.
How is it used and dosed?
The dose and duration of treatment are decided by the doctor. The doses below are taken from the official patient leaflet (PIL) – do not change them yourself.
| Indication | Adults | Over 65 years and people with heart disease |
|---|---|---|
| Depression | initially 25 mg twice daily; the doctor may gradually increase up to 150 mg daily, divided into two doses | initially 10–25 mg daily; gradually up to 100 mg daily in two doses (100–150 mg requires closer monitoring) |
| Neuropathic pain, prevention of tension-type headache and migraine | initially 10–25 mg in the evening; usually 25–75 mg daily (above 100 mg daily closer monitoring is needed) | initially 10–25 mg in the evening; above 75 mg daily closer monitoring is needed |
| Bedwetting in children | Dose |
|---|---|
| under 6 years | must not be used |
| 6–10 years | 10–20 mg daily (a pharmaceutical form suitable for this age is needed) |
| 11 years and older | 25–50 mg daily |
- For bedwetting the dose is increased gradually and the medicine is taken 1–1.5 hours before bedtime; an ECG is performed before starting, and after three months the doctor reassesses treatment.
- Tablets can be taken with or without food and are swallowed whole with a glass of water – do not chew.
- In depression, improvement usually appears after several weeks and treatment usually lasts at least 6 months; in pain, too, the effect may take several weeks.
- If the doctor adds an SSRI antidepressant, the amitriptyline dose may be adjusted.
Special patient groups
- Children and adolescents: for depression, neuropathic pain, tension-type headache and migraine the medicine is not given to people under 18; for bedwetting it may be used from 6 years, with an ECG before starting and without concomitant anticholinergics.
- Elderly patients: start with lower doses; dizziness on standing (orthostatic hypotension), confusion and delirium are more common.
- Liver impairment: the medicine must not be taken in severe liver disease; in other liver disease and in “poor metabolisers” lower doses are usually given, and the doctor may measure blood levels of the medicine.
- Heart disease: lower starting doses and closer monitoring are needed; in some heart conditions the medicine is contraindicated (see below).
- Diabetes: dose adjustment may be needed.
Contraindications – when the medicine must not be used
Do not take Amitriptyline Remedica:
- if you are allergic to amitriptyline or any of the excipients;
- if you have recently had a myocardial infarction (heart attack);
- if you have heart problems such as a heart rhythm disorder seen on an ECG, heart block or coronary artery disease;
- if you are taking MAO inhibitors or have taken them in the last 14 days (and conversely: after stopping amitriptyline, wait 14 days before starting an MAO inhibitor);
- if you have taken moclobemide in the last 24 hours;
- if you have severe liver disease;
- in children under 6 years of age.
Precautions and warnings
- High doses, and also usual doses in people with heart disease, may cause heart rhythm disorders and a drop in blood pressure; QT interval prolongation has been reported. Tell your doctor if you have a slow heart rate, heart failure, low or high potassium or low magnesium, take medicines that affect the heart, or have an overactive thyroid.
- Suicidal thoughts and worsening depression: the risk is highest at the start of treatment and in people under 25; it may help if someone close to you watches for changes in mood and behaviour.
- In manic-depressive illness a switch into a manic phase is possible.
- Caution is needed in narrow-angle glaucoma, epilepsy, difficulty passing urine and enlarged prostate, thyroid disease, bipolar disorder, schizophrenia, pyloric stenosis and paralytic ileus, diabetes and phaeochromocytoma.
- Before planned surgery the doctor may stop amitriptyline; always inform the anaesthetist and your dentist (local anaesthesia) about the treatment.
- Concomitant use with buprenorphine can cause serotonin syndrome.
- Serious skin reactions (DRESS) have been reported – stop taking the medicine and seek help immediately if a widespread rash, high fever and enlarged lymph nodes occur.
- The medicine contains lactose monohydrate – if you are intolerant to some sugars, consult your doctor.
Interactions with other medicines, food and drink
Tell your doctor about all medicines you take. According to the leaflet, the following are especially important:
- MAO inhibitors (phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine) and selegiline – must not be combined;
- adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (may be present in cold medicines and anaesthetics);
- blood pressure medicines: calcium channel blockers (diltiazem, verapamil), guanethidine, betanidine, clonidine, reserpine, methyldopa;
- anticholinergics (e.g. entacapone, atropine, hyoscyamine), thioridazine, nefopam, tramadol, morphine and buprenorphine;
- antifungals (fluconazole, terbinafine, ketoconazole, itraconazole), barbiturates, other antidepressants (fluoxetine, paroxetine, fluvoxamine, duloxetine, bupropion);
- beta blockers and antiarrhythmics, cimetidine, methylphenidate, ritonavir, oral contraceptives, rifampicin, linezolid, phenytoin, carbamazepine, valproic acid, baclofen, thyroid medicines, sublingual nitroglycerin and isosorbide dinitrate;
- St John’s wort (herbal preparation) – do not take without your doctor’s advice;
- medicines affecting heart rhythm: quinidine, sotalol, astemizole, terfenadine, pimozide, sertindole, cisapride, halofantrine, methadone and diuretics (e.g. furosemide).
Alcohol: not advised during treatment, as it increases the sedative effect.
Pregnancy and breastfeeding
Use during pregnancy is not recommended unless the doctor considers it clearly necessary. If the medicine is taken in the last weeks of pregnancy, the newborn may show withdrawal symptoms (irritability, increased muscle tension, tremor, irregular breathing, poor drinking, loud crying, urinary retention and constipation).
The doctor decides on breastfeeding, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.
Driving and using machines
Amitriptyline Remedica may cause drowsiness and dizziness, especially at the start of treatment. If you notice these symptoms, do not drive or operate machinery.
Possible side effects
Contact your doctor immediately if you notice: signs of QT prolongation or irregular heartbeat (common); constipation, swollen abdomen, fever and vomiting (possible paralysis of part of the bowel – rare); yellowing of the skin and eyes (rare); bruising, bleeding, pallor or persistent sore throat with fever (possible blood disorder – rare); suicidal thoughts (rare); attacks of blurred vision, rainbow halos and eye pain (possible acute glaucoma – very rare).
| Frequency | Side effects (selection from the PIL) |
|---|---|
| Very common (more than 1 in 10) | drowsiness, light-headedness, tremor, dizziness, headache, drop in blood pressure on standing, palpitations, dry mouth, constipation, nausea, excessive sweating, weight gain, slurred speech, aggression, blocked nose |
| Common (up to 1 in 10) | confusion, sexual dysfunction, attention disorder, altered taste, tingling in hands and feet, impaired coordination, dilated pupils, heart block, fatigue, low blood sodium, restlessness, urination disorders, thirst |
| Uncommon (up to 1 in 100) | agitation, anxiety, insomnia, nightmares, convulsions, ringing in the ears, high blood pressure, diarrhoea, vomiting, rash and hives, difficulty passing urine, milk discharge, raised eye pressure, worsening heart failure, impaired liver function |
| Rare (up to 1 in 1,000) | decreased appetite, delirium and hallucinations (especially in the elderly), irregular heart rhythm, swollen salivary glands, hair loss, sensitivity to sunlight, breast enlargement in men, weight loss |
| Very rare and not known | heart muscle disease, akathisia, peripheral nerve disease, torsade de pointes, allergic lung inflammation; changes in blood sugar, paranoia, hepatitis, anaphylaxis, DRESS |
An increased risk of bone fractures has been observed in patients taking medicines of this group. In children treated for bedwetting, side effects are less frequent (most often drowsiness, blurred vision, dilated pupils, constipation, sweating, itching and dry mouth).
Overdose, missed dose and stopping treatment
- Overdose is dangerous: symptoms include dilated pupils, fast or irregular heartbeat, dry mouth, difficulty passing urine, seizures, fever, confusion and hallucinations, low blood pressure, breathing difficulty, drowsiness, loss of consciousness and coma. Contact a doctor or the nearest hospital immediately, even without symptoms, and take the pack with you.
- Missed dose: take the next dose at the usual time; do not take a double dose.
- Stopping treatment: the doctor decides when and how to reduce the medicine gradually; stopping suddenly may cause headache, nausea, insomnia and irritability, and symptoms of the illness may return.
When to seek medical help immediately?
- thoughts of self-harm or suicide;
- irregular, very fast or slow heartbeat, fainting or chest pain;
- sudden blurred vision, rainbow halos around lights and eye pain;
- constipation with a bloated abdomen, fever and vomiting;
- yellowing of the skin or eyes;
- widespread rash with high fever and enlarged lymph nodes, swelling of the face, lips or throat and difficulty breathing;
- suspected overdose (especially in a child).
Pharmacist's advice
For neuropathic pain and headache prevention amitriptyline is usually taken in the evening because it causes drowsiness – many patients tolerate this well, but in the first days be careful when getting up and when driving.
Dry mouth and constipation are very common side effects: regular fluid intake, a fibre-rich diet and mouth-moisturising gels help. Do not take St John’s wort preparations or cold medicines with ephedrine or phenylephrine on your own without checking with a pharmacist.
Do not expect an immediate effect on mood or pain – it takes several weeks. Keep the medicine out of the reach of children, as overdose with tricyclic antidepressants is particularly dangerous.
Availability and price
Amitriptyline Remedica is a prescription-only medicine and cannot be ordered via this page. This page is not an offer for online purchase.
Please check availability and dispensing conditions at a pharmacy with a valid prescription.
Related information
For questions about neuropathic pain, headache or depression, talk to your doctor or pharmacist.
Composition, packaging and manufacturer
- Active substance: amitriptyline hydrochloride – 10 mg or 25 mg in one film-coated tablet.
- Excipients (core): microcrystalline cellulose; sodium starch glycolate (type A); lactose monohydrate; povidone; maize starch; colloidal anhydrous silica; magnesium stearate; talc.
- Coating: hypromellose; macrogol 400; titanium dioxide; talc; Brilliant blue FCF E133 (10 mg) or Quinoline yellow E104 (25 mg).
- Appearance: 10 mg – light blue, round film-coated tablets; 25 mg – yellow, round film-coated tablets.
- Pack: 10 mg – 100 film-coated tablets; 25 mg – 30 film-coated tablets.
- Marketing authorisation holder: FARMALOGIST D.O.O. BEOGRAD, Mirijevski bulevar 3, Belgrade; manufacturer: REMEDICA LTD, Limassol, Cyprus.
- Authorisations: 10 mg – 002113685 2024 of 09.05.2025; 25 mg – 002114073 2024 of 09.05.2025.
Storage
- Keep out of the sight and reach of children.
- Store below 25 °C in the original package to protect from light and moisture.
- Do not use after the expiry date; return unused medicine to a pharmacy that collects unused medicines.
Frequently asked questions
Is Amitriptyline Remedica used only for depression?
No. According to the leaflet it is also used for neuropathic pain, for the prevention of chronic tension-type headache and migraine in adults, and for bedwetting in children over 6 years when other treatments have not helped. Doses for pain and headache are usually lower than for depression.
When is it taken – morning or evening?
For neuropathic pain and headache prevention the starting dose is taken in the evening. For depression the dose is usually divided into two daily doses, and for bedwetting the medicine is taken 1–1.5 hours before bedtime. The schedule is set by the doctor.
How long does it take to work?
Improvement in mood or reduction of pain usually appears after several weeks of regular use. Treatment of depression usually lasts at least 6 months, so the medicine should not be stopped as soon as you feel better.
Can I drink alcohol while taking amitriptyline?
It is not advised, because alcohol increases the sedative effect of the medicine (drowsiness, slowness), which increases the risk of falls and traffic accidents.
Sources
- ALIMS – Patient leaflet Amitriptyline Remedica, 10 mg and 25 mg, film-coated tablets (May 2025, in Serbian)
- ALIMS – Summary of product characteristics Amitriptyline Remedica, 10 mg and 25 mg (in Serbian)
Date sources were checked: 24.10.2026.
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