Patient leaflet - METHAROSE SUGAR FREE 1 MG / 1ML ORAL SOLUTION
1. what metharose is and what it is used for
The name of your medicine is Metharose. It contains methadone hydrochloride.
This medicine has been prescribed for you to treat opioid drug addiction or moderate to severe pain. It contains the methadone which belongs to a class of medicines called opioids.
This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have discussed how long you will be taking it for and when it is appropriate to stop, how to do this safely.
2. what you need to know before you take metharose
Do not take Metharose and tell your doctor if:
- you are allergic to methadone or any other ingredients of this medicine (listed in section 6). An allergic reaction can include a rash, itching or shortness of breath
- you have severe breathing problems or a history of asthma. You must not use this medicine during an asthma attack. If you give this medicine to yourself
(self-administration), wait until the asthma attack has passed and you are fully recovered
- you are addicted to alcohol
- you have a head injury and the pressure inside your brain is higher than it should be (check this with your doctor). You might be getting bad headaches
- you are taking Monoamine Oxidase Inhibitors (MAOIs) used to treat depression or if you have taken a MAOI medicine in the past two weeks (see ‘Other medicines and Metharose’)
- you are dependent on any other drugs
- you are in labour
- you have phaeochromocytoma, a tumour of the adrenal glands
- you have a bowel disorder known as paralytic ileus
- children must not be given this medicine.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking Metharose.
Warnings and precautions
Talk to your prescriber before taking this medicine for pain relief if you:
- have ever been addicted to opioids, alcohol, prescription medicines or illegal drugs
- have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
- feel you need to take more of Metharose to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.
Taking this medicine regularly, particularly for a long time, can lead to addiction. Your
(A) prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.
Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.
Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
Talk to your doctor before taking Metharose if:
- you have liver or kidney problems
- you have problems with your gallbladder and bile duct
- you have epilepsy
- you have low thyroid function (hypothyroid)
- you have problems with your adrenal glands. These are linked to your kidneys ®
- you have an enlarged prostate gland
- you have low blood pressure
- you are in shock
- you have a muscle weakness disease called myasthenia gravis
- you have bowel problems
- you have a history of irregular heart beat
- you have a history of heart disease
- you have a family history of people dying suddenly without cause
- you have low potassium, sodium or magnesium levels
- you are pregnant or breast-feeding
- you are extremely ill or an older person. You may be more sensitive to the medicine
- you are taking medicines called CNS depressants to treat anxiety, acute stress and panic attacks
- you have weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be a symptom of the adrenals producing too little of the hormone cortisol, and you may need to take hormone supplement.
Long-term use may cause decreased sex hormone levels and increased levels of the hormone prolactin. Contact your doctor if you experience symptoms such as decreased libido, impotence or absence of menstruation (amenorrhea).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Metharose. „
Other medicines and Metharose
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription, including herbal medicines. This is because Metharose can affect the way some other medicines work. Also some medicines can affect the way Metharose works.
The risk of side effects increases, if you use methadone concomitantly with antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, amitriptyline, clomipramine, imipramine, nortriptyline). Contact your doctor if you experience symptoms such as:
- mental-status changes (e.g. agitation, hallucinations, coma)
- fast heartbeat, unstable blood pressure, fever
- exaggeration of reflexes, impaired coordination, muscle stiffness
- gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
You must not take Metharose:
- at the same time or within 2 weeks of taking Monoamine Oxidase Inhibitors (MAOIs). Some medicines can increase the risk of heart problems when used with Metharose.
Talk to your doctor before taking Metharose if you are taking:
- medicines for heart problems such as verapamil and enalapril
- medicines which affect electrolyte balance such as diuretics (water tablets) or lithium. zz
Tell your doctor if you are taking any of the following medicines:
- medicines that dull your senses such as:
– medicines to help you sleep (including anaesthetics) and medicines to calm you down called tranquillisers
- serotonergic medicines used to treat migraine, such as sumatriptan
- cimetidine, used to treat stomach ulcers
- rifampicin, used to treat tuberculosis (TB)
- medicines used to treat epilepsy such as phenytoin, carbamazepine, phenobarbital and primidone
- medicines that make your urine acidic such as ascorbic acid (vitamin C)
- narcotic painkillers such as codeine and pentazocine
- naloxone used to reverse the effects of opioid drugs
- medicines used to stop opioid drugs working such as naltrexone and buprenorphine
- medicines used to treat HIV such as nevirapine, efavirenz, abacavir and nelfinavir. The doctor may have to change the amount of methadone you take whilst on these medicines
- antibiotics such as ciprofloxacin or macrolide antibiotics for example erythromycin
- medicines used to treat fungal infections such as ketoconazole or fluconazole
- St. John’s Wort – a herbal preparation for depression
- cyclizine, domperidone and metoclopramide, or serotonergic anti-emetics medicines such as ondansetron, used to treat nausea and vomiting
- medicines used to treat Parkinson’s disease and atropine @
- mexiletine used to treat unusual heart rhythms
- lofexidine or clonidine, used to treat withdrawal effects
- other opioid type drugs e.g. morphine
- medicines used to treat pain and fever such as metamizole
- concomitant use of Methadone and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe Methadone together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Other medicines you may be taking can also affect the heart. You must tell your doctor about any other medicines that you are taking as they may be dangerous if they are taken with methadone.
In these situations your doctor may decide that it is necessary to monitor your heart with an electrocardiogram (ECG) at the start of treatment to ensure that these effects do not occur.
If any of the above apply to you, talk to your doctor before taking Metharose.
Metharose with food and drink
Do not drink alcohol whilst taking Metharose. This is because Metharose can make you feel sleepy and drinking alcohol will make you even more sleepy.
Grapefruit juice may effect how your methadone works.
Pregnancy and Breast-feeding
- take care if you are taking a pregnancy test as the methadone may interfere with the results
- you should not take this medicine whilst you are in labour
- talk to your doctor if you are breast-feeding or thinking of breast-feeding while you are taking methadone as it may affect your baby. Monitor your baby for abnormal signs and symptoms such as increased drowsiness (more than usual), breathing difficulties or limpness. Consult your doctor immediately if you notice any of these symptoms.
Driving and using machines
Metharose can severely affect your ability to drive or use machines as it may make you sleepy or dizzy. You should only start doing these activities again with the permission of your doctor.
- Do not drive while taking this medicine until you know how it affects you.
- It is an offence to drive if this medicine affects your ability to drive.
- However, you would not be committing an offence if:
– The medicine has been prescribed to treat a medical or dental problem and
– You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
– It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Metharose contains methyl and propyl parahydroxybenzoates, liquid maltitol and propylene glycol:
- methyl (E218) and propyl parahydroxybenzoates (E216). These may cause allergic reactions (possibly delayed).
- liquid maltitol (E965). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Liquid maltitol may have a mild laxative effect and has a calorific value of 2.3kcal/g.
- propylene glycol (E1520). This medicine contains 103.7mg propylene glycol per 5ml. If you are pregnant, breast-feeding or if you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
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500ml Metharose ® Sugar Free 1mg/1ml Oral Solution Methadone Hydrochloride
Can cause addiction Contains opioid
Each 5ml contains 5mg Methadone C
Hydrochloride.
This product also includes methyl and propyl hydroxybenzoates (E218 and E216), propylene glycol (E1520) and liquid maltitol (E965).
See leaflet for further information.
Administration:
For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage:
Do not store above 25°C. Protect from light. Keep out of the sight and reach of children.
Manufactured by the MA Holder:
Rosemont Pharmaceuticals Ltd., Leeds LS11 9XE, UK.
PL 0427/0106
C7G77RBF5
3. How to take Metharose
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your prescriber should have discussed with you, how long the course of this medicine will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
Taking this medicine
- this medicine contains 1mg of methadone in each 1ml
- take this medicine by mouth.
Adults
For addiction
- the starting dose is 10mg to 20mg (10ml to 20ml) each day
- the doctor can increase this to 40mg to 60mg (40ml to 60ml) each day.
For pain
- the usual dose is 5mg to 10mg (5ml to 10ml) every 6 to 8 hours
- the dose may be changed by your doctor. (12)
Older people and very ill people
- if you have to have repeated doses of this medicine, the doctor may want to monitor you more closely.
Use in children
Children must not take this medicine.
If you take more Metharose than you should
- if you take more of this medicine than you should, talk to a doctor or go to your nearest hospital straight away. Take the medicine pack with you
- the signs you may notice are difficulty in breathing; feeling very drowsy which may lead to a stupor or coma; very small pupils; cold and clammy skin; a very slow pulse rate; low blood pressure and muscle weakness. In extreme cases, you may stop breathing, your blood flow may stop, you may have a heart attack which could lead to death
- it can result in low blood sugar.
If you forget to take Metharose
- if you forget a dose do not take it. Wait until the next dose is due and take only that amount
- do not take a double dose (two doses at the same time) to make up for a forgotten dose.
<13
If you stop taking Metharose
Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.
Pregnancy
Do not take Metharose if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.
If you use Metharose during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Metharose can cause side effects although not everybody gets them.
Stop taking this medicine and see a doctor straight away if you have an allergic reaction to Metharose.
An allergic reaction may include:
- swelling of your face, lips, tongue or throat or difficulty breathing or swallowing
- severe itching of your skin with raised lumps.
Stop taking this medicine and see a doctor straight away if you have any of the following:
- heart problems. The signs of this may include changes in the way your heart beats, such as it beating faster or missed heart beats, breathing difficulties and dizziness
- if your breathing becomes slow and shallow
- worsening of the pressure inside your head if you already have this condition following an injury to your brain or brain disease.
Keep taking the medicine but tell your doctor straight away if you get any of the following side effects:
- if you have asthma and it gets worse.
Tell your doctor if you get any of these side effects:
Very common (affects more than 1 in 10 people)
- feeling sick (nausea) or being sick (vomiting).
Common (affects less than 1 in 10 people)
- feeling weak, tired
- weight gain
- water retention
- constipation
- rash, that may appear and disappear
- sweating a lot more than usual
- blurred vision, small pupils, dry eyes
- feeling of dizziness, spinning sensation
- changes in your mood, feeling “high” or over excited, feeling drowsy
- seeing or hearing things that are not there (hallucinations).
Uncommon (affects less than 1 in 100 people)
- feeling dizzy, particularly when standing up. This may be a sign that you have low blood pressure
- headache
- feeling down (dysphoria), agitation, confusion, difficulty sleeping
- itching, rashes
Not known (frequency cannot be estimated from the available data)
- reduction in blood platelets, which increase the risk of bleeding or bruising
- high prolactin levels in the blood
- rapid, uncontrollable movements of the eyes
- low blood sugar
- dependence and addiction (see section ‚How do I know if I am addicted?‘).
Drug Withdrawal
When you stop taking Metharose, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating. @
How do I know if I am addicted?
If you notice any of the following signs whilst taking Metharose, it could be a sign that you have become addicted.
- you need to take the medicine for longer than advised by your prescriber
- you feel you need to use more than the recommended dose
- you are using the medicine for reasons other than prescribed
- when you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.
If you notice any of these signs, it is important you talk to your prescriber.
The following side effects have also been reported
- loss of appetite
- swollen arms and legs. This may be a sign of your body holding onto more water than usual
- low potassium and magnesium which will be found by blood tests
- eye and eyesight problems in babies and young children born to mothers who used methadone during pregnancy
- reduction in the body’s normal production of adrenal and sexual hormones.
You may notice that some of the side effects become less severe with time as you get used to the methadone.
When taken for a long period of time, it is possible that you may become dependent on Metharose. (18
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
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 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 Metharose
- Keep out of the sight and reach of children
- Store below 25°C. Protect from light
- Do not use after the expiry date (month, year) stated on the label and carton
- If it is out of date or you no longer want it, take it back to the pharmacy
- Do not use Metharose if you notice anything wrong with the medicine. Talk to your pharmacist
- 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 Metharose contains
- The active ingredient is methadone hydrochloride
- The other ingredients are methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol (E1520), caramel (E150), liquid maltitol (E965) and purified water.
What Metharose looks like and contents of the pack
- A brown solution.
It comes in a brown glass bottle holding 500ml of solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd., Yorkdale Industrial Park, Braithwaite Street,
Leeds, LS11 9XE, UK
This leaflet was last revised in 01/2021.
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500ml Metharose ® Sugar Free 1mg/1ml Oral Solution Methadone Hydrochloride
Each 5ml contains 5mg Methadone Hydrochloride.
POM CD
This product also includes methyl and propyl hydroxybenzoates (E218 and E216), propylene glycol (E1520) and liquid maltitol (E965).
See leaflet for further information.
Can cause addiction Contains opioid
Manufactured by the MA Holder: Rosemont Pharmaceuticals Ltd., Leeds LS11 9XE, UK.
PL 0427/0106
system
Administration:
For oral use.
Read the package leaflet before use.
This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how it makes you feel.
See the leaflet inside for more information.
Storage:
Do not store above 25°C. Protect from light.
Keep out of the sight and reach of children.
Rosemont®
Base Page
144 × 70mm
C7G77RBF5
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ARTWORK VERSION:
1
Date: Date:
220/1/21 –
Operator: Operator:
NH –
JOB INFORMATION JOB SPECIFICATION
The source of liquid solutions. A PerrigO * Company
| Product Name: Metharose® Sugar Free 1 mg/1 ml Oral Solution (Methadone Hydrochloride) Strength: 1mg/1ml New Item Code: C7G77RBF5 Pack Size: 500ml Previous Item Code: C7G77RBF4 Bottle Size: 508ml Supplier Code: N/A Design Icon: CNS Change Control No.: 1404985 | Keyline Ref: UKLB148 Pharmacode: 832 Dimensions: 70×971 mm EAN Code: 5 016119 132599 Folded Size: 70 × 144mm No. of Colours: 3 + Varnish N/A Page Number: 1 of 1 |
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