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MANEVAC

Active substance(s): ISPAGHULA HUSK / ISPAGHULA HUSK POWDERED / ISPAGHULA SEED / ISPAGHULA SEED POWDERED / TINNEVELLY SENNA PODS

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Transcript
(Ispaghula Seed, Ispaghula Husk
and Tinnevelly Senna Pods)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 7 of days.
What is in this leaflet:
1. What Manevac is and what it is used for
2. What you need to know before you take Manevac
3. How to take Manevac
4. Possible side effects
5. How to store Manevac
6. Contents of the pack and other information
1. What Manevac is and what it is used for
Manevac is one of a group of medicines called laxatives. The medicine contains Ispaghula Seed, Ispaghula Husk
(bulk-forming laxatives) and Tinnevelly Senna Pods (a stimulant laxative). Manevac can be used occasionally to relieve
constipation (infrequent passing of hard stools).
Manevac is also used to maintain normal bowel action in bed-ridden patients and pregnant women. Manevac can
also help reduce pain when emptying the bowels for patients suffering from haemorrhoids (piles).
Manevac does not help with weight loss.
2. What you need to know before you take Manevac
Do not take Manevac
• if you are allergic to Ispaghula Seed, Ispaghula Husk, Tinnevelly Senna Pods or any of the other ingredients of this
medicine (listed in section 6).
(An allergic reaction can be a rash, itchiness or shortness of breath).
• if you have narrowing of the gastrointestinal tract
• if you have difficulty in swallowing or any throat problems
• if you have a blocked bowel (intestinal obstruction or paralysis of the intestines)
• if you suffer from any bowel disorders, for example ulcerative colitis, Crohn’s disease, appendicitis or enlarged bowel
(megacolon)
• if you have diabetes which is difficult to control
• if you have unexplained tummy pain
• if you are severely dehydrated
• in children under 12 years of age.
Talk to your doctor before taking this product if any of the above applies to you.
Warnings and precautions
• Take each dose of Manevac with 1-2 glasses of water or similar drink, such as milk or fruit juice. Taking Manevac without enough liquid may cause it to swell and block your throat, and may cause choking. If you have chest pain, vomiting, or difficulty in swallowing or breathing after taking Manevac, get medical attention straight away. (See “How to
take Manevac” in section 3.)
• Do not exceed the stated dose.
• Make sure you drink enough while taking Manevac. This will also help your constipation.
• Only take Manevac if your doctor tells you to do so:
• if you are weak, frail or elderly (you will need to be monitored while taking Manevac)
• if you have a blocked bowel (dried, hard stools with tummy pain, nausea and vomiting).
• If you get tummy pain or your stools are different in some way, stop taking Manevac and see your doctor.
• If you need to use laxatives every day for your constipation, see your doctor. Do not use laxatives for a long time unless your doctor tells you. Using stimulant laxatives (such as Senna pods) more often than occasionally can slow down
your bowel and make your constipation worse (called ’lazy bowel syndrome’).
• See your doctor before taking Manevac if you are already taking:
• medicines for heart failure or irregular heart beat
• any medicines that may affect your heart rhythm (QT-prolongation seen on an ECG trace)
• water tablets (diuretics)
• certain steroids used for inflammation
• liquorice root.
(See also ‘Taking other medicines’ below.)
• Talk to your pharmacist or doctor for advice if you have kidney problems.
• If you are incontinent, your pads should be changed more frequently.
• You should first try taking more exercise, changing your diet or taking bulking agents to relieve your constipation before taking laxatives. Ask your pharmacist or doctor for advice.
Information for diabetics
Speak to your doctor before taking Manevac if you are diabetic (each measuring spoon or sachet contains approximately 1.04g of sucrose).
If this applies to you it is important that you speak to your doctor or pharmacist before taking Manevac and they will
decide what to do. It may still be safe for you to take Manevac.
Other medicines and Manevac
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines
obtained without a prescription.
In particular tell your doctor or pharmacist about:
• mineral or vitamin B12 supplements
• medicines for heart failure (cardiac glycosides)
• medicines to thin the blood such as warfarin
• carbamazepine for epilepsy (fits)
• lithium for bipolar disorder.
Do not take Manevac within ½ to 1 hour before or after these medicines.
• insulin
If you are diabetic and use insulin, you may need to reduce your dose of insulin if you take Manevac with meals.
• medicines for thyroid problems
Your doctor may need to change the dose of the thyroid hormones you are taking.
Long-term misuse of laxatives increases the side effects of:
• medicines for heart failure or heart rhythm
• water tablets (diuretics)
• certain steroids used for inflammation
• liquorice root.
It may still be safe for you to take Manevac; your doctor or pharmacist will be able to advise you further.
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. It is best not to use Manevac during the first three months of preg-

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SPECIFICATION BOX: Beipackzettel
PRODUCT:

Manevac Granules 400 g
Black

MEDA-NO.:

56UK2149261-00

MFS-NO.:

902006

LAETUS-CODE: 297
EAN-CODE:

---

COUNTRY:

UK

SIGHTMARKS:

---

LANGUAGE:

Englisch

PACK-SIZE:

184 x 378 mm

CORRECTION: 1. Corr.

FONT-SIZE:

Avant Garde Gothic 8,8 pt

DATE:

03.11.2015

nancy. Manevac should only be used occasionally and only if changes in diet or the use of bulking agents have not worked.
Do not use Manevac if you are breast-feeding as small amounts of some of the ingredients may get into your milk.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while breast-feeding.
Driving and using machines
Manevac has no known effect on your ability to drive and use machines.
Important information for patients with an intolerance to some sugars
Manevac contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.
3. How to take Manevac
If this product has been prescribed by your doctor, the label on the pack will tell you how much you should take and
when. Always take Manevac exactly as your doctor has told you. If you are pregnant, it is best not to use Manevac
during the first three months of pregnancy. You should check with your doctor or pharmacist if you are not sure about
taking Manevac.
Manevac should be placed dry on the tongue and, without chewing or crushing, swallowed with plenty of water, warm
drink, milk, fruit juice, or similar liquid (approximately 1-2 glasses with each level measuring spoon or sachet).
Drink about 5-10 glasses of fluid every day while you are taking this product.
Dose
Adults (including pregnant women), the elderly and children over 12 years
The usual dose for adults, the elderly and children over 12 years is one or two level measuring spoons OR one or two sachets
(equivalent to 5g or 10g of granules respectively) once a day at night. But do not take it immediately before bedtime.
Take the dose at least ½ to 1 hour before or after taking other medicines.
Take the smallest dose to produce comfortable soft stools.
The maximum daily dose is two level measuring spoons or two sachets (10g of granules) of Manevac.
Normally you will need to take Manevac no more than two or three times a week. Do not use for longer than 1 – 2 weeks
unless your doctor agrees. If the symptoms persist while using Manevac, talk to your doctor or a pharmacist.
(See “Take special care with Manevac” in section 2.)
Use in children and adolescents
Manevac is not recommended for children under 12 years of age.
If you take more Manevac than you should
If you take too much Manevac contact your nearest casualty department or tell your doctor or pharmacist immediately. Take this leaflet and any remaining granules with you.
It may be harmful to
• Take too much Manevac or
• Take Manevac for too long
This is because taking too much for too long may lead to:
- A ‘lazy bowel’, where the muscle in the bowel becomes too relaxed. This means that bowel emptying happens less
often. This can lead to long-term constipation.
- Imbalance of fluid and salts in the body. This can affect the tightness of muscles such as those in the bowel. It can also
affect the salts in the blood.
- Low levels of potassium in the blood (called ‘hypokalaemia’). This can make you tired, dizzy, make your muscles weak
and cause an uneven heart-beat.
Dehydration, making you thirsty, feel faint and giving you headaches. It can also mean you cannot pass enough urine.
If you forget to take Manevac
If you forget to take your Manevac, just take your normal dose as soon as you remember. Do not take a double dose to
make up for a forgotten dose.
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.
If you get any of the following side effects you should stop taking Manevac and tell your doctor immediately or go to
the casualty department of your nearest hospital, as these may be signs of an allergic reaction to the medicine:
• a skin rash resembling hives (itchy, raised, swollen areas on the skin) or nettle rash
• itchiness or redness
• shortness of breath
Flatulence (wind) may occur for a short time after starting Manevac.
Manevac may produce tummy pain, tummy cramps and runny stools, in particular in patients with irritable bowel. However,
these symptoms may also occur if too much Manevac has been taken. If this is the case, take less Manevac.
Swollen tummy, blockage in the throat or gut and blocked bowel (dried, hard stools collected in the rectum and anus)
may occur, particularly if insufficient fluid is drunk.
The frequency of these side effects is not known.
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 Yellow Card Scheme (Website: www.yellowcard.mhra.gov.uk). By reporting
side effects you can help provide more information on the safety of this medicine.
5. How to store Manevac
Keep this medicine out of the sight and reach of children.
Do not use Manevac after the expiry date, which is stated on the pack. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if you notice description of the visible signs of deterioration.
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 to protect the environment.
6. Contents of the pack and other information
What Manevac contains
The active substances are Ispaghula Seed, Ispaghula Husk and Tinnevelly Senna Pods.
Each 5g dose contains:
2.6g of Ispaghula Seed (Plantago ovata Forssk.);
0.11g of Ispaghula Husk (Plantago ovata Forssk.);
0.34-0.66g of Tinnevelly Senna fruit (Cassia angustifolia Vahl) corresponding to 15mg hydroxyanthracene glycosides
calculated as sennoside B.
The other ingredients are caraway oil, Spanish sage oil, peppermint oil, acacia, talc, iron oxides (E172), hard paraffin,
liquid paraffin and sucrose.
What Manevac looks like and contents of the pack
Manevac is presented as brown sugar-coated granules and is available in
• packs containing 400g of granules
Marketing Authorisation Holder and Manufacturer
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road - Takeley
Bishop’s Stortford - CM22 6PU, UK
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
HFA Healthcare Limited
Solihull, B91 1NF, UK
Tel: 0844 335 8270.
Manevac is a registered Trade Mark
902006
This leaflet was last revised in October 2015.
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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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