powder for oral solution, sachet

What Lacrofarm Junior is and what it is used for

The name of this medicine is Lacrofarm Junior. It is a laxative for the treatment of chronic constipation in children from 2 to 11 years and for the treatment of very severe constipation (so-called fecaloma) in children from 5 to 11 years.


It helps your child to have a pleasant bowel function even if constipation has lasted for a long time.

Macrogol, sodium chloride, potassium chloride, sodium bicarbonate contained in Lacrofarm Junior may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before giving Lacrofarm Junior

Do not give Lacrofarm Junior if your doctor has told you that your child has:

  • allergy to macrogol 3350, sodium chloride, sodium bicarbonate, potassium chloride or any of the other ingredients of this medicine (listed in section 6).
  • ulcers in the intestinal wall.
  • constrictions in the intestine (intestinal obstruction, ileus ).
  • severe inflammatory bowel disease such as ulcerative colitis, Crohn’s disease or toxic megacolon.

Warnings and cautions

When your child takes Lacrofarm Junior, the child should continue to drink a lot. The fluid in Lacrofarm Junior should not replace your baby’s normal fluid intake.

If your child has heart or kidney problems, vomiting, or reflux oesophagitis (heartburn caused by a reflux of stomach contents to the esophagus), you should talk to your doctor before giving Lacrofarm Junior.


If your child develops symptoms such as swelling, shortness of breath, fatigue, dehydration (symptoms are increased thirst, dry mouth, and weakness), and heart problems, you should stop giving your child Lacrofarm Junior and contact your doctor immediately. The symptoms have been seen in the treatment of adults.

Use of other medicines

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines. Some drugs, e.g. against epilepsy, may be less effective with concomitant use of Lacrofarm Junior. When your child takes large amounts of Lacrofarm Junior (eg for feces), your child should not take any other medicines within one hour before or after taking Lacrofarm Junior.

Pregnancy and breastfeeding

Lacrofarm Junior can be used during pregnancy or breastfeeding.

Talk to your doctor or pharmacist before giving Lacrofarm Junior.

Driving and using machines

Lacrofarm Junior does not affect the ability to drive or use machines.

Lacrofarm Junior contains sodium

This medicine contains 93 mg (4.06 mmol) of sodium (the main ingredient in table salt/table salt) per sachet. This corresponds to 4.7% of the highest recommended daily intake of sodium for adults.

How to give Lacrofarm Junior

Always take Lacrofarm Junior exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.


Chronic constipation:

The dose of a Lacrofarm Junior depends on the age of the child and how it responds to the treatment.

  • As a starting dose, 1 sachet should be given daily to children from 2 to 6 years.
  • 2 sachets daily should be given to children from 7 to 11 years.
  • Your doctor may ask you to increase the number of sachets until your child has a soft stool. Normally no more than 4 sachets per day are needed.

It is not necessary to take the whole drink at the same time, if your child prefers, half the drink can be taken in the morning and a half in the evening.


Fecal:

Before your child takes Lacrofarm Junior for feces, it should be medically confirmed that your child has this condition.


A treatment regimen for fecaloma in children from 5 to 11 years is as follows: Show larger

Number of sachets
Age (years) Day  1 Day  2 Day  3 Day  4 Day  5 Day  6 Day  7
5 – 11 4 6 8 10 12 12 12


The daily number of sachets is divided into several occasions. All doses should be taken within 12 hours (eg 08: 00-20: 00). Treatment can be stopped when the medicine has worked. This is shown by the fact that your child has large amounts of feces and/or watery diarrhea.


How to use Lacrofarm Junior

  • Open the sachet and dissolve the contents in a glass. Fill with ¼ glass of water (approx. 62.5 ml). Stir well until all the powder has dissolved.
  • For the treatment of fecal matter, it may be easier to dissolve 12 bags in 750 ml of water.

Duration of treatment

  • Chronic constipation: The treatment must last for a long time, at least 6-12 months.
  • Fecalom : Treatment with Lacrofarm Junior can be up to 7 days.

If your child has received too much Lacrofarm Junior

Your child may have diarrhea. Stop giving Lacrofarm Junior until diarrhea subsides and then continue with a lower dose.

Contact a doctor, hospital, or the Poison Information Center (tel. 112) for advice if you are worried or if someone has ingested the medicine by mistake.

If you forget to give your child Lacrofarm Junior

Give dose one as soon as you remember it and then continue as before. 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, pharmacist, or nurse.

Possible side effects

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


Contact your doctor immediately and stop giving Lacrofarm Junior to your child if your child gets:

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

  • a severe allergic reaction that causes difficulty breathing and dizziness, or swelling of the face, lips, tongue or throat.
  • signs of allergy such as rash, itching or shortness of breath.

The following side effects have also been reported:

Common (may affect up to 1 in 10 people)

  • A rumbling stomach, swollen stomach or stomach pain, gas, vomiting, nausea, indigestion or soreness in the tail (bottom). If your child experiences mild diarrhea when they start taking Lacrofarm Junior, this usually gets better when dose one of Lacrofarm Junior is reduced.

Has been reported (occurs in an unknown number of users):

  • Reddening of the skin or hives
  • Swelling of hands, feet or ankles.
  • Headache
  • High and low levels of potassium in the blood.

How to store Lacrofarm Junior

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the sachet and carton after EXP. The expiration date is the last day of the specified month.

Once you have mixed Lacrofarm Junior with water and your child cannot drink it immediately, cover it and store it in the refrigerator (2 ° C-8 ° C). Solution not used within 24 hours should be discarded.

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.

Contents of the pack and other information 

Content declaration

  • The active substances are macrogol 3350 (6.563 g), sodium chloride (175.4 mg), sodium bicarbonate (89.3 mg) and potassium chloride (23.3 mg).
  • The other ingredient is acesulfame potassium (E950) as a sweetener.

What the medicine looks like and contents of the pack

Lacrofarm Junior is a white powder packaged in sachets.

It is available in packs containing 2, 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S
Energivej 15

5260 Odense S
Danmark


Local representative

Orifarm Generics AB
Box 56048

102 17 Stockholm

info@orifarm.com

Muhammad Nadeem

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