Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Optimax 500mg Capsules
⚠ This medicine appears to have been discontinued
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 Tryptophan may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
•
The name of your medicine is Optimax 500mg capsules, which will be referred to as Optimax throughout this leaflet. Optimax contains the active substance L-tryptophan. L-tryptophan belongs to a group of medicines called antidepressants. Optimax is used in adults for treatment-resistant depression. This means that it is used together with other antidepressants in people who have tried these alone for a period of time, but have failed to recover.
•
2.
What you need to know before you take it
e Optimax
Do not take Optimax: • •
If you are allergic to L-tryptophan or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include skin rash, swelling of the face, wheezing or difficulty breathing. If you have had eosinophilia myalgia syndrome (EMS, a blood problem that increases white blood cells called eosinophilia and causes severe muscle pain) after taking any form of L-
tryptophan (the active ingredient in Optimax). Warnings and precautions Talk to your doctor or pharmacist before taking Optimax. Take special care with Optimax and tell your doctor if you: • • •
have problems with your liver, blood or kidneys have ever had thoughts about killing or harming yourself (see the following section) are under age 25 (see the following section)
Thoughts of suicide and worsening of your depression or anxiety disorder If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer. You may be more likely to think like this: –
If you have previously had thoughts about killing or harming yourself. If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think that your depression or anxiety is getting worse, or if they are worried about changes in your behaviour. Children Optimax is not recommended for children. Other medicines and Optimax Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Usually Optimax is only prescribed by your doctor together with other medicines to treat your depression. Taking Optimax may worsen the side effects of the other medicines. These include: • •
• •
Monoamine oxidase inhibitors (MAOIs), such as phenelzine and moclobemide, and tranylcypromine. 5-HT reuptake inhibitors (also called serotonin inhibitors, selective serotonin reuptake inhibitors or SSRIs) such as citalopram, dapoxitine, paroxetine, and fluoxetine. With SSRIs, a problem called serotonin syndrome can occur. The potential for this may also occur with SNRIs (serotonin/norepinephrine reuptake inhibitors) such as duloxetine, and the appetite suppressant sibutramine. Serotonin syndrome can cause agitated behavior, sleeplessness, aggression, sickness, diarrhoea, stomach pain, poor coordination and headache. Please consult your doctor if you notice any of these symptoms. levodopa, a medicine used in the treatment of Parkinson's disease, may be less effective if used at the same time as Optimax. antipsychotic (phenothiazine) or anti-anxiety (benzodiazepine) drugs, such as chlorpromazine and diazepam. These have caused loss of the usual social inhibitions about sexual matters.
Optimax with food and drink You should avoid drinking alcohol during treatment with anti-depressants. 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 for advice before taking this medicine. Optimax should not be taken when breast-feeding. Driving and using machines L-tryptophan may cause drowsiness. When you first start to take Optimax you should avoid driving or operating machinery until you know whether your alertness is affected. 3.
How to take it
Optimax
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The capsules should be swallowed whole, preferably after food. The recommended dose is for: Adults The usual starting dose is two capsules, three times a day (morning, midday and evening). This may be increased to four capsules, three times a day if your doctor thinks it is necessary. Elderly Your doctor may tell you to take fewer capsules each day. Duration of treatment: Take your capsules for as long as your doctor says. You may need to take Optimax for many months, it may take some time for the capsules to work. If you take more Optimax than you should Too much of this medicine can make you drowsy and feel sick. If you or anyone else takes too much of this medicine, contact your doctor or hospital immediately. Take this leaflet with you to show what you have swallowed. If you forget to take Optimax Do not take a double dose to make up for a forgotten dose. If you stop taking Optimax Talk to your doctor before you stop taking Optimax and follow their advice. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects with Optimax, STOP taking the capsules and contact your doctor immediately: A severe allergic reaction, such as itching, swelling of the face, lips, tongue, mouth, or throat, which may cause shortness of breath, wheezing, or difficulty breathing. Very rarely, the active ingredient in Optimax has caused a disease called Eosinophilia Myalgia Syndrome (EMS). If you develop symptoms of fever, muscle or joint pains or a rash, you should see your doctor as soon as possible. The following side effects have been reported: • • • •
feeling sick (nausea) headache light headedness suicidal thoughts or behaviour (see section 2)
Reporting 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 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. 5.
How to store it
Optimax
Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month. Use within three months of the first opening. 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. 6.
Contents of the pack and other information
What Optimax contains The active substance is 500 mg L-tryptophan. The other ingredients are povidone, sodium starch glycolate, silica colloidal anhydrous, magnesium stearate and silicon dioxide. The capsule shell consists of gelatin and titanium dioxide (E171). What Optimax looks like and contents of the pack Optimax are white capsules.
Optimax is available in plastic containers of 84 capsules. Marketing Authorisation Holder Esteve Pharmaceuticals Ltd., The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berks. SL6 6PT, United Kingdom Manufacturer
Tarchomińskie Zakłady Farmaceutyzne "Polfa" S.A. ul. A. Fleminga 2, Warszawa, 03-176, Poland This leaflet was last revised in March 2022.
Frequently asked questions about Optimax 500mg Capsules
How do I take Optimax 500mg Capsules?
Optimax 500mg Capsules comes as capsule containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Optimax 500mg Capsules?
The active substance in Optimax 500mg Capsules is tryptophan.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Optimax 500mg Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Optimax 500mg Capsules without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: tryptophan
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment-resistant depression after trials of standard antidepressant drug treatments and as an adjunct to other anti-depressant medication.
Treatment with Optimax should only be initiated in adults by hospital specialists. Patients may subsequently be prescribed Optimax in the community by their general practitioner.
4.2. Posology and method of administration
Posology
For oral use.
Paediatric population
The safety and efficacy of Optimax in children have not been established.
Adults
The usual dose is two capsules, three times daily; for some patients, up to 6g L-tryptophan may be required.
Elderly
A lower dose may be appropriate, especially where there is evidence of renal or hepatic impairment.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients with a previous history of eosinophilia myalgia syndrome (EMS) following the use of L-tryptophan. This syndrome, which is a multisystem disorder, is characterised by raised eosinophils (>1.0 x 109/L), and severe myalgia in the absence of either an infectious or neoplastic cause. (see sections 4.4 and 4.8)
Patients with a known hypersensitivity to the active substance or any of the excipients.
4.4. Special warnings and precautions for use
Suicide/suicidal thoughts or clinical worsening
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Eosinophilia Myalgia Syndrome
Eosinophilia Myalgia Syndrome (EMS) has been reported in association with the use of oral L-tryptophan-containing products. It is a multisystem disorder which is usually reversible but, rarely, fatal. Products containing contaminants such as 1,1′- ethylidenebis[l-tryptophan] are suspected to cause EMS. An immunogenetic susceptibility can not be ruled out. Various investigations have not as yet identified the aetiological factors precisely.
The symptoms of EMS have been reported to include eosinophilia, arthralgia, myalgia, myopathy, fever, dyspnoea, neuropathy, sedation, somnolence, drowsiness, peripheral oedema, asthenia, fatigue, increase of hepatic transaminases, rash and skin lesions which can include sclerosis or papular and urticarial lesions.
Caution should be exercised with patients who experience some but not all of the symptoms of EMS after taking L-tryptophan. Treatment should be withheld and the symptoms investigated until the possibility of EMS can be excluded. (see sections 4.3 and 4.8)
Serotonin syndrome
The possible interaction between L-tryptophan and 5HT reuptake inhibitors could lead to the “serotonin syndrome” characterised by a combination of agitation, restlessness and gastro-intestinal symptoms including diarrhoea. Combinations with 5HT reuptake inhibitors should only be used with care (see Section 4.5).
4.5. Interaction with other medicinal products and other forms of interaction
Where L-tryptophan is combined with MAO Inhibitors such as phenelzine, moclobemide and tranylcypromine the side effects of the latter may be enhanced.
Use of L-tryptophan in combination with SSRI such as dapoxitine, citalopram fluoxetine, and paroxetine has the potential for increasing the severity of the adverse effects of SSRIs and could lead to serotonin syndrome (see Section 4.4). The potential for this may also occurs with SNRIs such as duloxetine, and the appetite suppressant sibutramine.
Plasma levels of levodopa have been reduced significantly when L-tryptophan (1g) was used concurrently with levodopa (500mg).
In patients taking L-tryptophan in conjunction with phenothiazines or benzodiazepines there have been isolated reports of sexual disinhibition.
4.6. Fertility, pregnancy and lactation
No clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ fetal development, parturition or postnatal development (see section 5.3).
Caution should be exercised when prescribing to pregnant women.
Due to the absence of any clinical data relating to the use of Optimax in nursing mothers, Optimax should not be taken during breast feeding.
No data relating to fertility are available for Optimax.
4.7. Effects on ability to drive and use machines
L-tryptophan may produce drowsiness. Patients who drive and operate machinery should be warned of the possible hazard.
4.8. Undesirable effects
In some patients, L-tryptophan may cause a slight feeling of nausea which usually disappears within 2 or 3 days. Such nausea can be minimised by giving L-tryptophan after food. Other adverse reactions include headache and light-headedness.
Cases of suicidal ideation and suicidal behaviours (frequency not known) have been reported during L-tryptophan therapy or early after treatment discontinuation (see section 4.4).
Cases of Eosinophilia Myalgia Syndrome (EMS) (see section 4.4) have been reported. Please refer to section 4.4 for additional symptoms associated with the development of EMS. The frequency of these events is unclear from the available data but no further new reported instances have appeared for over 20 years.
System Organ Class
Preferred Term
Frequency
Blood and lymphatic disorders
Eosinophilia myalgia syndrome
Not known
Psychiatric disorders
Suicidal ideation
Not known
Suicidal behaviours
Not known
Nervous system disorder
Headache
Not known
Light-headedness
Not known
Somnolence
Not known
Sedation
Not known
Vascular disorders
Oedema
Not known
Musculoskeletal and connective tissue disorders
Myalgia
Not known
Gastrointestinal disorders
Nausea
Not known
General disorders
Asthenia
Not known
Fatigue
Not known
Myopathy
Not known
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Drowsiness and vomiting may occur; supportive measures should be employed.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- KetosterilL-Lysini acetas 105 mg + L-Threoninum 53 mg + L-Tryptophanum 23 mg + L-Histydyna
- Vamin 18 Electrolyte-FreeGlycinum 7.9 g + Isoleucinum 5.6 g + Treoninum 5.6 g + Tryptophanum 1.9 g + L-Gl
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 about this leaflet
Ask anything about Optimax 500mg Capsules. 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.