LOMONT 70MG/5ML ORAL SUSPENSION

Active substance: LOFEPRAMINE HYDROCHLORIDE

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Patient Information Leaflet

If you get any of the following side effects, see your doctor as soon as possible:
n Effects on your heart: feeling faint and dizzy when standing up, change in blood pressure, fast or unusual heart
beats, heart failure becoming worse
n Effects on your brain and nervous system: feeling confused, feeling agitated, feeling disorientated (not knowing
where you are), delusions and hearing or seeing things that are not there (hallucinations), difficulty sleeping,
nightmares, feeling slightly hyperactive, numbness or tingling or pins and needles (particularly in the hands and
feet), difficulty in co-ordinating movements, fits
n Effects on your liver: hepatitis including changes in liver function that would be identified by a blood test, yellowing
of the skin and the whites of your eyes (jaundice)
n Effects on your hormones: change in sexual function and sex drive,
breast swelling in men and women, production of breast milk, pain
in the testicles, increased or decreased blood sugar levels,
inappropriate secretion of the hormone ADH (antidiuretic hormone)
that may make you pass water (urinate) more frequently.
Tell your doctor if you get any of these side effects:
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.
n Effects on your ears: buzzing or ringing in the ears
n Effects on your stomach and intestines: feeling or being sick, nasty taste in your mouth, dry mouth, constipation,
diarrhoea
n Effects on the skin: skin rashes, skin rash due to sunlight, swollen face, bleeding from the skin, swelling of the moist
areas of the body such as the nose
n Effects on your eyesight: blurred or double vision, changes in eyesight, glaucoma
n General effects: headache, dizziness, tiredness, increased sweating, difficulty passing water, shaking.
An increased risk of bone fractures has been observed in patients taking this type of medicine.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet.



5. How to store Lomont 70mg/5ml Oral Suspension

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Keep out of the reach and sight of children.
Store between 4°C and 25°C. Store away from direct light.
Do not use after the expiry date (month, year) stated on the label and carton. The expiry date refers to the last
day of that month.
n If it is out of date or you no longer want it, take it back to the pharmacy.
n Do not use Lomont 70mg/5ml Oral Suspension if you notice anything wrong with the medicine. Talk to your
pharmacist.
n Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicine no longer required. These measures will help to protect the environment.



6. Further information

What Lomont 70mg/5ml Oral Suspension contains
n The active ingredient is lofepramine hydrochloride.
n The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene
glycol (E1520), sodium ascorbate (E301), sorbitol solution 70% non-crystallising (E420), liquid maltitol (E965),
ethanol, colloidal silicon dioxide, cherry flavour and purified water.
What Lomont 70mg/5ml Oral Suspension looks like and contents of the pack
A white to pale yellow/orange suspension with a cherry odour.
It comes in a brown glass bottle holding 150ml of suspension.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
This leaflet was last approved in 07/2012

SPC update



Lomont 70mg/5ml Oral Suspension
lofepramine hydrochloride

Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
This medicine has been prescribed only for you. Do not pass
it on to others. It may harm them, even if their symptoms are
the same as yours.
n If any of these side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.
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In this leaflet
1. What is Lomont 70mg/5ml Oral Suspension and what is it used for
2. Before you take Lomont 70mg/5ml Oral Suspension
3. How to take Lomont 70mg/5ml Oral Suspension
4. Possible side effects
5. How to store Lomont 70mg/5ml Oral Suspension
6. Further information

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1. What is Lomont 70mg/5ml Oral Suspension and what is it used for

The name of your medicine is Lomont 70mg/5ml Oral Suspension. This belongs to a group of medicines called tricyclic
antidepressants.
Lofepramine alters the levels of chemicals in your brain to relieve the symptoms of depression.
Lofepramine can be used to treat the symptoms of depression.



2. Before you take Lomont 70mg/5ml Oral Suspension

Do not take Lomont and tell your doctor if:
n you are allergic (hypersensitive) to lofepramine, other tricyclic antidepressants such as clomipramine and
imipramine or any other ingredients in this liquid (see section 6). An allergic reaction can include a rash, itching
or shortness of breath
n you are pregnant, likely to become pregnant or breast-feeding
n you suffer from periods of increased and exaggerated unusual behaviour (mania)
n you have liver or kidney disease
n you have heart problems including unusual heart beats, heart block or if you have recently had a heart attack
n you have untreated glaucoma (raised pressure of the fluid inside the eye)
n you suffer from prostate problems and have problems passing urine
n you suffer from chronic constipation
n you are suffering from alcohol or drug poisoning
n you are suffering from mental confusion (deliria)
n you are taking MAOIs, amiodarone or terfenadine (see ‘Taking other medicines’ section).
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor before taking Lomont.
Take special care with Lomont
Before you take this medicine, tell your doctor if:
n you have epilepsy or you are experiencing withdrawal from alcohol or epileptic drugs
n you have an enlarged prostate gland
n you have increased pressure in your eye (known as narrow-angle glaucoma)
n you have thyroid problems or you are taking medicine to treat a thyroid problem
n you have a mental illness such as manic depression
n you are having electroconvulsive therapy (ECT)
n you have a problem with your blood called porphyria or other blood problems
n you have tumour of the adrenal gland (phaeochromocytoma or neuroblastoma)
n you have high blood pressure. Your doctor may want to check your blood pressure before starting you on treatment
with lofepramine
n you or members of your family have a history of irregular heart beats or other heart problems
n you have been told by your doctor that you have low sodium or potassium levels.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Lomont.
Continued overleaf

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. This is because these medicines all take about two weeks
but sometimes longer to work properly.
You may be more likely to think like this if:
n you have previously had thoughts about killing or harming yourself.
n you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults
less than 25 years with psychiatric conditions who were treated with an antidepressant.

Babies born to mothers who have taken tricyclic antidepressants may suffer from withdrawal symptoms, difficulty in
breathing and agitation.
Talk to your doctor before breast-feeding because Lomont passes into breast milk.
Driving and using machines
Lomont may make you feel drowsy. If you experience this, do not drive or use machinery. The amount of alcohol in
Lomont may also affect your ability to drive or use machines.
Important information about what is in Lomont:
This medicine contains:
n methyl and propyl parahydroxybenzoates. These may cause an allergic reaction. This
allergy may happen some time after starting the medicine
n liquid maltitol and sorbitol solution (types of sugar). If your
doctor has told you that you cannot tolerate some sugars, talk to
your doctor before taking this medicine
n ethanol (alcohol). Each 5ml spoonful contains 10%v/v ethanol
which is equal to 10ml of beer or 4ml of wine. Speak to your
doctor before taking this medicine if you have an addiction to alcohol, liver disease,
epilepsy, brain injury or disease, you are pregnant or if this medicine has been prescribed
for a child.

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 your depression
or anxiety is getting worse, or if they are worried about changes in
your behaviour.
Lomont is not suitable for use in children or adolescents under the age of 18.
Having operations and tests
Tell your doctor, anaesthetist or dentist that you are taking lofepramine if you are going to have an anaesthetic for an
operation or dental treatment.
Taking other medicines
Please 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.
Do not take Lomont if you are taking the following medicines:
n medicines to treat depression known as Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine or you have
taken MAOIs within the last 14 days
n amiodarone, used to control the way your heart beats
n terfenadine, used to treat allergies.



3. How to take Lomont 70mg/5ml Oral Suspension

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you
are not sure.
Taking this medicine
n this medicine contains 70mg of lofepramine in each 5ml
n take this medicine by mouth
n shake the bottle well before using.
The usual doses are given below. These may be changed by your doctor:

In particular tell your doctor if you are taking any of the following medicines:
n other medicines used to treat depression including Serotonin Selective Reuptake Inhibitors (SSRIs) such as
fluoxetine and fluvoxamine or drugs that control your moods or alprazolam which makes you feel less anxious
n medicines that may interfere with the electrical conduction of the heart such as certain antibiotics (e.g. macrolides),
anti-malarials, anti-histamines or medicines used to treat psychiatric problems or depression
n medicines used to treat heart problems such as:
- guanethidine, betanidine, resperine, clonidine and methyldopa, or other medicines used to treat high
blood pressure
- calcium channel blockers such as diltiazem or verapamil
- digoxin
- nitrates used to treat angina
- medicines that control the heart beat such as sotalol, disopyramide, procainamide, propafenone and quinidine
n warfarin used to prevent your blood clotting. Your doctor may want to perform some tests
n diuretics (water tablets).
Also:
n medicines found in cough and cold remedies such as phenylephrine or phenylpropanolamine. Tell your pharmacist
that you are taking lofepramine before buying these medicines
n medicines used to treat epilepsy including barbiturates such as phenobarbital
n medicines that lower blood potassium levels such as diuretics, e.g. loop diuretics, (e.g. furosemide) which are
commonly used to treat high blood pressure or thiazide diuretics (e.g. hydrochlorothiazide) which are mainly used to
treat heart failure
n disulfiram - used to treat patients with alcohol problems
n medicines used to treat Parkinson’s disease
n ritonavir - used to treat HIV
n cimetidine - used to treat stomach acid problems
n medicines to treat thyroid problems
n altretamine used to treat ovarian cancer
n rifampicin used to treat tuberculosis (TB)
n oral contraceptives
n painkillers.

Stop taking Lomont and see a doctor straight away if you have:
n an allergic reaction. Signs may include swelling of your face, lips, tongue or throat or difficulty breathing or
swallowing severe itching of your skin with raised lumps
n a serious effect on your blood, such as low sodium levels. Signs may include fever or chills, sore throat, ulcers in
your mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruises. These may also be
signs of other blood disorders. If you notice any of these, tell your doctor straight away.

Taking Lomont with food and drink
Do not drink alcohol whilst taking Lomont.

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Older people
Your doctor will start you on a lower dose and gradually increase it as you may be more sensitive to the medicine.
Children
This medicine should not be used in children.
If you take more Lomont 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.
If you forget to take Lomont
n If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the
missed dose
n Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Lomont
Do not stop taking the medicine unless your doctor tells you to. If you stop taking the medicine abruptly, you may get
withdrawal effects such as feeling irritable, unable to sleep and sweating more than usual.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.



4. Possible side effects

Like all medicines, Lomont can cause side effects although not everybody gets them.

Serious side effects: tell a doctor straight away
If you feel more depressed, including thinking about suicide.

Pregnancy and Breast-feeding
Talk to your doctor before taking this medicine if you are pregnant or planning to become pregnant.





Adults
The usual dose is 70mg (5ml of suspension) two to three times a day.

SPC update

Continued overleaf

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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