Patient leaflet - Primidone Rosemont 250 mg/5 ml oral suspension

1.What Primidone Rosemont is and what it is used for

The name of your medicine is Primidone Rosemont 250mg/5ml Oral Suspension. In this leaflet the shorter name primidone is used.

Primidone belongs to a group of medicines used to treat seizures.

Primidone is used for the treatment of certain types of epilepsy, seizures (fits) or shaking attacks (essential tremor).

2.What you need to know before you take Primidone Rosemont

Do not take primidone:

if you are allergic to primidone, phenobarbital, or to any of the other ingredients of this medicine (listed in section 6)
if you have porphyria (a rare inherited disorder of metabolism) or anyone in your family has it. ^■Do not give this medicine to your child if they are less than 4 weeks old or weigh 4 kg or less.This is because the medicine contains propylene glycol, which can cause harmful side effects in very young or small children.

Warnings and precautions

This medication is not effective in certain forms of epilepsy.Your doctor will assess the need to prescribe you this medicine depending on the form of epilepsy you are suffering from.

Consult your doctor immediately if the frequency of your seizures increases or if seizures of a different type appear.

Talk to your doctor or pharmacist before taking primidone:

if you have ever had respiratory, kidneys or liver problems
if you are pregnant or are trying to become pregnant (see below for further information). If you go into hospital, tell the medical staff that you are taking primidone.

Your doctor may prescribe you Vitamin D supplementation (in case of long-term treatment). A small number of people being treated with anti-epileptics such as primidone have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS syndrome) have been reported with the use of primidone, appearing initially as reddish target like spots or circular patches often with central blisters on the trunk.

Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).

These potentially life-threatening skin rashes are often accompanied by flu-like symptoms.The rash may progress to widespread blistering or peeling of the skin.

The highest risk for occurrence of serious skin reactions is within the first weeks of treatment. If you have developed Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS syndrome with the use of primidone or any other medicine containing phenobarbital, you must not be re-started on these medicines at any time.

If you develop a rash or these skin symptoms, stop using primidone and seek immediate advice from a doctor and tell him that you are taking this medicine.

Other medicines and primidone

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because some medicines may affect the way primidone works, or primidone may affect the way other medicines work.

In particular, tell your doctor if you are taking any of the following:

other medicines used to treat epilepsy and other types of seizures (such as phenytoin, felbamate, valproic acid, carbamazepine, perampanel, lamotrigine, oxcarbazepine, stiripentol, tiagabine, zonisamide), ^■anticoagulants to prevent blood clots (such as acenocoumarol, fluindione, phenindione, warfarin), ^■barbiturates or benzodiazepines (such as sleeping tablets),
medicines used to treat severe pain, cough, or as a substitute for morphine addiction (such as methadone, oxycodone or fentanyl),
antibiotics (such as metronidazole, doxycycline, telithromycine),
asthma medicines (such as theophylline, montelukast),
hormone containing medicines (such as the oral contraceptive pill, estroprogestatives, progestatives, ulipristal),
thyroid hormones,
cyclosporin (used to prevent rejection of an organ transplant and also for other diseases of the body’s immune system),
medicines used to treat mental health problems or depression (such as lurasidone, tricyclic antidepressants, lamotrigine, mianserin, quetiapine, sertraline),
steroid-containing medicines,
medicines used to treat cancer (such as cyclophosphamide, etoposide, abiraterone, axitinib, eribuline, ifosfamide, bosutinib, crizotinib, dabrafenib, dasatinib, erlotinib, gefitinib, imatinib, lapatinib, nilotinib, pazopanib, ruxolitinib, sorafenib, sunitinib, vandetanib, regorafenib, vemurafenib, vismodegib, cabozantinib, ceritinib, ibrutinib, olaparib, ponatinib, cabazitaxel, docetaxel, irinotecan, procarbazine), ^■St-John’s wort,
medicines containing morphine or similar medicines called opiates,
bedaquiline, delamanid (used to treat tuberculosis),
quinine (used to treat malaria),
medicines used to treat viral infections such as HIV infection or hepatitis C (such as boceprevir, cobicistat, daclatasvir, dasabuvir, dolutegravir, lopinavir, maraviroc, nelfinavir, ombitasvir+paritaprevir, rilpivirine, ritonavir, simeprevir, sofosbuvir, telaprevir),
anti-fungal medicines (voriconazole, albendazole, itraconazole, posaconazole),
anticoagulants (such as apixaban, dabigatran, rivaroxaban or ticagrelor),
folates (vitamin B9),
medicines used to reduce immunity (immune-suppressants, such as cyclosporin, tacrolimus, sirolimus, everolimus),
deferasirox (iron-chelator),
medicine used to treat cystic fibrosis (ivacaftor),
medicines used to treat a heart disease, high blood pressure or to regulate cardiac rhythms (such as class IA antiarythmics, calcium antagonists, bosentan, dronedarone, ivabradine, macitentan, nimodipine, propafenone, ranolazine or betablockers (metoprolol, propranolol),
antiparasite agent (albendazole, praziquantel).

Taking primidone with food, drink and alcohol

Alcohol can react with primidone. Ask your doctor for advice if you want to drink alcohol. Pregnancy, breast-feeding and fertility

Pregnancy

If taken during pregnancy, primidone which is extensively metabolised to phenobarbital can cause serious birth defects and can affect the way in which the child develops as it grows. Birth defects which have been reported in studies include cleft lip (split in the top lip) and cleft palate (split in the roof of the mouth) and heart abnormalities. Other birth defects have also been reported, such as malformation of the penis (hypospadias), smaller than normal head size, facial, nail and finger abnormalities. If you take phenobarbital during pregnancy you have a higher risk than other women of having a child with birth defects that require medical treatment. In the general population, the baseline risk of major malformations is 2-3%.This risk is increased by about 3 times in women taking phenobarbital (main metabolite of primidone).

Primidone should not be used during pregnancy unless nothing else works for you. Talk to your doctor immediately if you are pregnant.Your doctor should discuss the possible effects of phenobarbital tablets on the unborn child and the risks and benefits of treatment should be considered carefully.

If you have taken Primidone during the last third of the pregnancy, appropriate monitoring should be conducted to detect potential disorders in the newborn, such as seizures, excessive crying, muscle weakness, sucking disorders.

Your doctor will talk to you about potential benefit of continuation of the treatment or whether another medication may be more suitable for you. If you continue treatment,

During pregnancy: your doctor will adjust your dose to get the minimum effective dose for you.
Before delivery: you will need to take vitamin K to prevent the bleeding this medicine may cause during the first 24 hours of your baby’s life.
After childbirth: an injection of vitamin K may also be prescribed to your baby, at birth, to avoid any bleeding.

Do not stop taking Primidone until you have discussed this with your doctor, as stopping the medication abruptly may increase the risk of developing seizures, which may have harmful effects on you and the unborn child.

Woman of child-bearing potential/Contraception

If you are a woman of childbearing age you should use effective contraception during treatment with Primidone and for two months after treatment. Primidone may affect how hormonal contraceptives, such as the contraceptive pill, work and make them less effective at preventing pregnancy.Talk to your doctor, who will discuss with you the most suitable type of contraception to use while you are taking Primidone. If you are a woman of childbearing age and are planning a pregnancy, talk to your doctor before you stop contraception and before you become pregnant about switching to other suitable treatments in order to avoid exposing the unborn baby to phenobarbital (primidone is extensively metabolized to phenobarbital). Effects in the newborn

The newborn child may develop withdrawal symptoms if the mother has taken Primidone in the late stages of pregnancy. Blood clotting problems have occurred occasionally in children born to women who were previously taking anticonvulsant drugs.

Babies born to mothers using Primidone during pregnancy may also be at increased risk of being smaller than expected.

Neurodevelopmental disorders (delays in development due to disorders in brain development) have been reported among children exposed to phenobarbital (main primidone metabolite) during pregnancy. Studies on the risk of neurodevelopmental disorders remain contradictory.

Breast-feeding

Breast-feeding is not recommended as primidone is found in breast milk and can make the baby sleepy. Contact your doctor if you are breastfeeding or want to breastfeed.

Driving and using machines

Primidone can make you feel sleepy. If so, do not drive or operate machinery.

Primidone Rosemont contains methyl and ethyl hydroxybenzoate, liquid maltitol and propylene glycol

methyl and ethyl hydroxybenzoate (E218 and E214). 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.
propylene glycol (E1520).This medicine contains 20 mg propylene glycol per ml. If your child is less than
5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol. Use in neonates less than 4 weeks of age and in children of body weights of 4kg or less is not recommended as the estimated daily exposure to propylene glycol exceeds the EMA-recommended safety thresholds. Neonates (term babies less than 4 weeks of age, and pre-term babies less than 44 post-menstrual weeks of age) are known to have immature metabolic and renal clearance of propylene glycol, leading to possible accumulation. Prolonged treatment and/or at very high dose in patients, increases the risk of serious adverse reactions such as metabolic acidosis (a condition in which the blood is too acidic), renal (kidney) dysfunction including acute tubular necrosis (damage to the structures in the kidneys that filter blood), acute renal failure and liver dysfunction. If you are pregnant or breast feeding, do not take this medicine unless recommended by your doctor.Your doctor may carry out extra checks while you are taking this medicine. 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.
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’. ^■Benzoic acid (E210), which may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to
4 weeks old).This medicine contains less than 0.02 mg per 1 ml dose.

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3. How to take Primidone Rosemont

Always take primidone exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

the dosage will be determined by your doctor and adjusted gradually on individual basis. ^■Primidone is normally taken twice a day.Try to take your dose at the same time each day. ^■This medicine contains 250mg of primidone in each 5ml of suspension. ^■Take this medicine by mouth with a glass of water.
Always shake the bottle before using it.
Always use the syringe supplied with the pack.

Epilepsy

At first, your dose may be as little as 125mg (2.5ml).This will be adjusted by your doctor until your condition is controlled.Typical maintenance doses are as follows:

Age group	Daily dose (mg)	Daily dose (ml)
Adults and children over 9 years	750 to 1500	15 to 30
Children 6 to 9 years	750 to 1000	15 to 20
Children 2 to 5 years	500 to 750	10 to 15
Children up to 2 years	250 to 500	5 to 10

Use in neonates less than 1 month old or less than 4 kg body weight is not recommended because of the potential adverse effects/toxicity from the excipient propylene glycol.

Shaking attacks (Essential tremor)

Your starting dose may be 50 mg (1ml).This will be adjusted by your doctor until your condition is controlled. The highest dose tolerated for shaking attacks (essential tremor) is up to a maximum of 750 mg (15ml). Elderly / Patients with renal or liver disease

Lower doses may be prescribed. Please check with your doctor.

Measuring your dose

Open the bottle: press the cap and turn it anticlockwise (figure 1)
Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed.
Take the syringe and put it in the adaptor opening (figure 4).Turn the bottle upside down (figure 5).
Fill the syringe with a small amount of suspension by pulling the plunger down (figure 5A), then push the plunger upward in order to remove any possible bubble (figure 5B). Pull the plunger down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).
Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).
Close the bottle with the plastic screw cap.
Empty the contents of the syringe into your mouth.
After dosing, wash the syringe with water only (figure 7).

If you take more Primidone than you should

If you take more than your normal dose, it may be associated with the following symptoms: coordination disorder of the muscles, unconsciousness, respiratory disorder and even coma.

If you take more than your normal dose, contact your doctor or nearest hospital IMMEDIATELY. If you forget to take primidone

If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking primidone

Do not stop taking your primidone, even if you are feeling well, unless your doctor tells you to. You may have become dependent on primidone, and therefore you could get a withdrawal reaction if you stop treatment too quickly. Primidone treatment should be reduced gradually to prevent this. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Common (may affect up to 1 in 10 people)

lack of energy (apathy), coordination disorders, visual disturbances, rolling of the eyes ^■nausea.

Uncommon (may affect up to 1 in 100 people)

headache, vertigo
vomiting
allergic skin reaction.

Rare (may affect up to 1 in 1,000 people)

decreased number of some blood cells (red blood cells or white blood cells or platelets) or development of lymph nodes
changes in mood or behaviour
joint or bone pain, Dupuytren’s contracture (a thickening of fibrous tissue in the palm of the hand that causes one or more fingers to drawback), osteomalacia (bone softening due to vitamin D deficiency) ^■exfoliative dermatitis (common redness and peeling of the skin), lupus eythematous (disease which causes inflammation of various parts of the body including the skin, joints, lungs, kidneys, heart and liver ^■raised levels of enzymes in your liver (gamma GT, alkaline phosphatase)

Very rare (may affect up to 1 in 10,000 people)

potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).

Not known (frequency cannot be estimated from the available data)

Suicidal ideation
Confusion
Hallucinations
Balance issues
allergic reactions which may include fever, rash, increased numbers of some blood cells (eosinophils), increased of some liver enzymes.
there have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone)
and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids.
potentially life-threatening skin rashes (drug rash with eosinophilia and systemic symptoms) have been reported (see section 2).
Itching (Pruritus)

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 theYellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRAYellow Card in the Google Play or Apple App Store. By reporting side affects you can help provide more information on the safety of this medicine.

5. How to store Primidone Rosemont

Keep this medicine out of the sight and reach of children.
Do not use Primidone after the expiry date which is stated on the carton as {EXP MMM/YYYY}.
The expiry date refers to the last day of that month
Do not store above 25ºC.

Use within 60 days of opening the bottle. 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.

6. Contents of the pack and other information

What Primidone Rosemont contains

The active substance is primidone. Each 5ml of oral suspension contains 250 mg primidone. ^■The other ingredients are methyl hydroxybenzoate (E218), ethyl hydroxybenzoate (E214), citric acid monohydrate (E330), trisodium citrate dihydrate (E331), polysorbate 80 (E434), simethicone emulsion 30% (benzoic acid (E210), polydimethylsiloxane (E900), polyethylene glycol sorbitan tristearate (E436), methylcellulose (E461), silica gel, polyethylene glycol stearate, sorbic acid (E200) and sulphuric acid (E513)), glycerol (E422), xanthum gum (E415), microcrystalline cellulose and carmellose sodium, liquid maltitol (E965), sucralose (E955), propylene glycol (E1520), tutti-frutti flavor (Glyceryl triacetate (E1518) and Alpha-tocopherol (E307)) and purified water.

What Primidone Rosemont looks like and contents of the pack

Primidone Rosemont is a white to off-white suspension. It comes in an amber PET bottle containing 150ml of suspension, with 10 ml oral dosing syringe and graduations every 1 ml and additional markings at each 0.25 ml with an adaptor.

The Marketing Authorisation Holder and Manufacturer is:

Marketing Authorisation Holder

Rosemont Pharmaceuticals Limited,Yorkdale Industrial Parks, Braithwaite Street, Leeds, LS11 9XE, UK. Tel: + 44 (0) 113 244 1400

Manufacturers

LM Manufacturing Limited, Sandretto Building, Cavalry Hill Industrial Park, Weedone, Northampton, NN7 4PP, UK.

This leaflet was last revised in April 2026.

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